PROTOCOL FOR CHRONIC BRONCHITIS - CTRI
A MULTICENTRIC OPEN CLINICAL TRIAL
TO EVOLVE A GROUP OF EFFICACIOUS HOMOEOPATHIC MEDICINES IN
‘SIMPLE AND MUCOPURULENT CHRONIC BRONCHITIS’
WITH REGARD TO IMPROVEMENT IN THE SYMPTOM COMPLEX OF
‘SIMPLE AND MUCOPURULENT CHRONIC BRONCHITIS’
PROTOCOL TEAM
COORDINATORS including programme officers & investigators
I. CHIEF CO-ORDINATOR: PROF C. NAYAK , DIRECTOR, CCRH, New Delhi.
II.CO-CHIEF CO-ORDINATORS:
1. Dr. Vikram Singh, Assistant Director, CCRH, New Delhi.
2. Dr. Hari Singh, Research Officer, CCRH, New Delhi.
III. CO-ORDINATOR: Dr. (Mrs.) Jaya Gupta, Research Officer, CCRH, New Delhi.
IV. PROGRAMME OFFICERS/ INVESTIGATORS
| |City |Site code |Centre |Programme Officer |Investigator(s) |consultant |
|a |Guwahati |RI 05 |Regional Research |Dr S. K. Sharma |Dr S. K. Sharma |medicine |
| | | |Institute | | | |
|b |Puri |RI 04 |Regional Research |Dr. B. K. Mondal |Dr. B. K. Mondal |medicine |
| | | |Institute | | | |
|c |Kottayam |CI 01 |Central Research Institute|Dr. T.N.S. Kurup |Dr.S. Gopinathan |medicine |
|d |Chennai |CU 01 |Clinical Research Unit |Dr. K.S.V. Bharathalaxmi |Dr. K. Raju |medicine |
|e |Bhopal |CE 01 |Clinical Research cum |Dr. D.D Arya |Dr. P.S. Chakravorty |medicine |
| | | |Epidemic Cell | | | |
|f |Pondicherry |CU 15 |Clinical Research Unit |Dr. S. Bhuvneshwari |Dr. Prakash Rao |medicine |
|g |Tirupati |CU 04 |Clinical Research Unit |Dr. G.Ravi Chandra Reddy |Dr. R.V. R. Prasad |medicine |
BUDGET: Expenditure will be met by CCRH, New Delhi.
|1. | INTRODUCTION |
| |1.1 |Literature review |
| | |Chronic bronchitis is a condition associated with excessive tracheobronchial mucus production sufficient to cause cough|
| | |with expectoration for at least 3 months of the year for more than 2 consecutive years. Simple Chronic bronchitis |
| | |describes a condition characterized by mucoid sputum production. Chronic mucopurulent bronchitis is characterized by |
| | |persistent or recurrent purulence of sputum in the absence of localized suppurative diseases such as bronchiectasis. |
| | |Since there may or may not be obstruction as assessed by the use of the forced expiratory vital capacity maneuver, |
| | |chronic bronchitis with obstruction deserves a separate classification. Cigarette smoking, air pollution, occupations |
| | |with exposure to inorganic organic gases, infections and familial and genetic factors contribute to the pathogenesis of|
| | |chronic bronchitis. The difference between chronic bronchitis with obstruction and asthma is based mainly on the |
| | |history of the clinical illness. The patient with chronic bronchitis with obstruction has a long history of cough and |
| | |sputum production with a later onset of wheezing, whereas the asthma patient with chronic obstruction gives a long |
| | |history of wheezing with later onset of chronic productive cough1 |
| | |The clinical presentation varies in severity from simple chronic bronchitis without disability to the severely disabled|
| | |state with chronic respiratory failure. Despite well-planned management, the patient with predominant bronchitis may |
| | |experience many episodes of respiratory failure from which recovery is frequent with proper therapy 1 |
| | |CCRH has conducted the study to see the effect of homoeopathic medicine on Bronchitis. The cases which were registered |
| | |were of Chronic Bronchitis and it is found that homoeopathic medicines have helped in alleviating sign and symptoms of |
| | |Chronic Bronchitis2 |
| | |It is apparent that so far no significant work has been done to elicit the efficacy of homoeopathic medicines in |
| | |chronic bronchitis and that there is no authentic record of homoeopathic medicine(s) for the treatment of the disease, |
| | |‘Chronic bronchitis’, in the homoeopathic repertories. As such, there is a need to explore the efficacy of homoeopathic|
| | |medicines otherwise indicated for the various diagnostic symptoms of chronic bronchitis in the Homoeopathic literature.|
| |1.2. | Classification: |
| | |Chronic bronchitis has been classified in the ICD-10, under item J41, as given below 3 : |
| | |J41 Simple and mucopurulent chronic bronchitis |
| | |Excludes : Chronic bronchitis: |
| | |NOS (J42) |
| | |Obstructive (J44.-) |
| | |J41.0 Simple chronic bronchitis |
| | |J41.1 Mucopurulent chronic bronchitis |
| | |J41.8 Mixed simple and mucopurulent chronic |
| | |bronchitis |
| | |It is also clear from the classification of Chronic lower respiratory diseases (J40-47) given in the ICD-10 that the |
| | |following conditions will be excluded from the purview of the current study: |
| | |Cystic fibrosis (E84.-) |
| | |Bronchitis, not specified as acute or chronic (J40) |
| | |Unspecified chronic bronchitis (J42) |
| | |Emphysema (J42) |
| | |Other chronic obstructive pulmonary diseases (J44) |
| | |Asthma (J45) |
| | |Status asthmaticus (J46) |
| |1.3. | Usefulness: |
| | |The present study plans to evolve a group of efficacious homoeopathic medicines in chronic bronchitis. It will define |
| | |the indications of medicines found effective in chronic bronchitis. This will be a valuable data for indexing in the |
| | |repertory and the same will immensely benefit the profession and the patients, at large. The results of the study will |
| | |also help in the verification of various clinical/additional symptoms of the medicines. These medicines will provide a |
| | |gentle, safe and cost effective treatment of the disease. |
|2. |Study Objectives: |
| |2.1 | Hypothesis |
| | |For the open clinical trial, the primary hypothesis is that the use of medicines selected on the basis of |
| | |repertorisation of the diagnostic signs and symptoms of chronic bronchitis and its characteristic symptoms, in single |
| | |dose, in a specific potency, would be effective in curing the patient suffering from chronic bronchitis. |
| |2.2. |Primary Objective |
| | |To carry out a multicentric open clinical trial of the medicines which will be selected after repertorisation of the |
| | |diagnostic symptoms of ‘Simple and Mucopurulent Chronic bronchitis’ , to determine therapeutic efficacy of these |
| | |medicines in Chronic bronchitis, thereby to evluate the efficacy of homoeopathic medicines for Chronic bronchitis. |
| |2.3. |Secondary Objective |
| | |To determine and verify characteristic symptoms of medicine(s) used. |
| | |To check the progression to complications. |
| | |To prevent the relapse. |
|3 | |STUDY DESIGN |
| |3.1. |Type of study |
| | |It will be an open clinical trial and cases will be enrolled from the General O.P.D. as and when they come till such |
| | |time that the target is achieved. |
| |3.2 |Approach |
| | |The study is designed to prove or disprove the hypothesis stated above. This is conditional on each study site adhering|
| | |to the protocol, ensuring quality control and minimizing loss to follow-up to below 5% and is also subject to the fact |
| | |that the studies continue till adequate sample size, specified below, is recruited. |
| |3.3. | Location |
| | |The following Institutes/Units have been selected for carrying out the research study keeping in view the adequacy of |
| | |the manpower, facilities of Lab investigations and the willingness of the research personnel at the institute: |
| | |Regional Research Institute, Guwahati (site code- RI 05) |
| | |Regional Research Institute, Puri (site code- RI 04) |
| | |Regional Research Institute, New Delhi (site code- RI 02) |
| | |Central Research Institute, Kottayam (site code- CI 01) |
| | |Clinical Research Unit, Chennai (site code- CU 01) |
| | |Clinical Research Unit, Pondicherry (site code- CU 15) |
| | |Clinical Research Unit, Tirupati (site code- CU 04) |
| |3.4 |Duration of Study |
| | |4 years and 1month |
| | |(2 years for the study + 2 years for the follow-up + 2months for the preparation of the concluding report.) |
| |3.5 | | |Flow chart of study design |
|4. | SELECTION AND ENROLMENT OF PATIENTS |
| |Patients presenting with constant cough with excessive tracheobronchial mucoid or mucopurulent expectoration for at least 3 |
| |months of the year for more than 2 consecutive years will be prescribed pre-selected medicine for a specific period, in a |
| |specified potency and posology. The periodic follow-up and assessment of these cases will be made for 2 years, at prescribed |
| |intervals. It will depend on the changes observed in the frequency, duration and intensity of the paroxysms of cough, |
| |expectoration, dyspnoea and crackles, as also on the changes observed in the PFT and the X-ray chest. Various aspects of the |
| |study treatment are highlighted below: |
|Patients presenting with constant cough with excessive tracheobronchial mucoid or mucopurulent expectoration for at least 3 months of the|
|year for more than 2 consecutive years will be prescribed pre-selected medicine for a specific period, in a specified potency and |
|posology. The periodic follow-up and assessment of these cases will be made for 2 years, at prescribed intervals. It will depend on the |
|changes observed in the frequency, duration and intensity of the paroxysms of cough, expectoration, dyspnoea and crackles, as also on the|
|changes observed in the PFT and the X-ray chest. Various aspects of the study treatment are highlighted below: |
| |4.1. |Diagnosis: 1,4 |
| | |4.1.1 |Symptoms, |
| | | | |
| | | |Patients who present with cough with scanty or copious mucoid and tenacious expectoration for three |
| | | |months or more for at least two consecutive years, in absence of a disease that could account for |
| | | |this symptom; |
| | | | |
| | | |Recurrent attacks of productive cough, usually in winter months, with steady increase in severity and|
| | | |duration in successive years until cough is present the year round. |
| | | |Shortness of breath and/or a feeling of tightness in the chest that is worse by exertion or mild |
| | | |physical activity. |
| | |4.1.2 |Signs |
| | | |Normally resonant Chest percussion note; and on auscultation, coarse ronchi (crackles) and wheezes |
| | | |that change in location and intensity after a deep and productive cough. |
| | |4.1.3 |Investigations: |
| | | |Normal Spirometry: |
| | | |FEV1: > 80% predicted |
| | | |FEV1/FVC > 0.7 |
| | | |Vital capacity, mildly diminished, |
| | | |Maximum expiratory flow rates , invariably low; |
| | | |Roentgenographic (X-ray) features: |
| | | |Thickened bronchial walls manifested by tubular or “tramline” shadows |
| | | |A generalized increase in bronchovascular markings. |
| | | |Pathological investigations |
| | | |Haemogram, ESR |
| | | |Sputum for AFB on three consecutive days (to rule out mycobacterium tuberculosis infection). |
| |4.2. | | Inclusion criteria: |
| | | |Diagnosed cases of Chronic Bronchitis as mentioned in (4.1) without any complications, from any sex |
| | | |and between 20 and 50 years of age fulfilling the following requirements: |
| | | |Willing to participate in the study and willing to come for the follow-up visits for two years at |
| | | |prescribed intervals, |
| | | |Residing within approachable distance from the center, |
| | | |Cases who are not, currently, on any other treatment, including homoeopathy, |
| | | |With cases who have taken any treatment, at least two-weeks’ treatment-free interval should have |
| | | |lapsed before the screening phase. |
| |4.3. | |Exclusion criteria: |
| | | |Subjects currently on any other treatment (Homoeopathy or other systems) |
| | | |Subjects who have discontinued treatment less than two weeks before, |
| | | |Chronic bronchitis, NOS(J42) and obstructive(J44) as per ICD 10 |
| | | |Subjects suffering from Emphysema, cor Pulmonale, Bronchial asthma, Bronchiectasis, Active pulmonary |
| | | |tuberculosis (open), Cystic fibrosis, Bronchopulmonary mycosis, Central airflow obstruction, Acute |
| | | |bronchitis, Pneumonia, Pulmonary thrombo-embolism, Left ventricular failure, Pulmonary hypertension, |
| | | |Chronic respiratory failure, Spontaneous pneumothorax, Bronchogenic carcinoma. |
| | | |Persons requiring oxygen therapy and hospitalization; |
| | | |Cough due to some other underlying disease. |
| | | |FEV,: < 80% PREDICTED |
| | | |FEV1 / FVC < 0.7 |
|5. |STATISTICAL PLAN |
| |5.1. |Sample size: |
| | |1050 cases will initially be enrolled in the study. |
| | |75 cases per year per centre for two years (keeping also a margin for the drop-out cases) |
| | |909 cases will be sufficient to assess outcome of improvement rate of 70% with absolute error of ±5% and with a |
| | |confidence level of 95%. |
| |5.2 | Statistical analysis |
| | |data obtained during the study would be analysed using appropriate statistical methods. |
|6. | Procedures for selection of medicine |
|6.1. Selection of the medicine: |
|The selection of the drugs has been arrived at by repertorising the symptoms |
|due to the Chronic Bronchitis. [2]. The repertorisation was done using the |
|Complete Repertory as the reference book. Considering the fact that the study|
|pertains to the Chronic Bronchitis , the drugs given in the first grade (3 |
|points) followed by those in the second grade (2 points) mentioned against |
|the rubrics “Chest; inflammation; Bronchial tubes” and ‘Chronic cough’ in the|
|Complete Repertory have been short-listed. To further minimize the variables,|
|the specific prescribing symptoms of each of these drugs have also been |
|worked out after repertorisation of all the relevant rubrics. |
| |
| |
|6.1.1 The signs and symptoms of ‘Chronic Bronchitis’ 1,4 : |
| |
|DEFINITIONS |
|EXAMINATION |
|INVESTIGATIONS |
| |
|Chronic bronchitis is a condition associated with excessive tracheobronchial mucus production sufficient to cause cough with expectoration|
|for at least 3 months of the year for more than 2 consecutive years. |
|The patient with predominant bronchitis is often overweight and cyanotic. There is apparently no apparent distress at rest, the |
|respiratory rate is normal or only slightly increased, and there is no apparent usage of accessory muscles. |
|Spirometry: Normal. |
|FEV1: > 80% predicted |
|FEV1/FVC > 0.7 |
|TLC is often normal |
|A moderate elevation of RV |
|Vital capacity, mildly diminished |
|Maximum expiratory flow rates, invariably low |
| |
|Simple Chronic bronchitis describes a condition characterized by mucoid sputum production. |
|Chest percussion note is normally resonant, and by auscultation one can usually hear coarse ronchi and wheezes that change in location and|
|intensity after a deep and productive cough. |
|Roentgenographic features: |
|Thickened bronchial walls manifested by tubular or “tramline” shadows and |
|A generalized increase in bronchovascular markings. |
| |
|Chronic mucopurulent bronchitis is characterized by persistent or recurrent purulence of sputum in the absence of localized suppurative |
|diseases such as bronchiectasis. |
| |
| |
| |
| |
| |
| |
| |
| | |
| |Chronic obstructive pulmonary disease (COPD) has been defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) |
| |as a disease state characterized by airflow limitation that is not fully reversible (). COPD includes |
| |Emphysema, an anatomically defined condition characterized by destruction and enlargement of the lung alveoli; |
| |Chronic bronchitis, a clinically defined condition with chronic cough and phlegm; and |
| |Small airways disease, a condition in which small bronchioles are narrowed. |
| |COPD is present only if chronic airflow obstruction occurs; chronic bronchitis without chronic airflow obstruction is not included |
| |within COPD. |
| | |
| | |
| | |
| |The patient with chronic bronchitis with obstruction has a long history of cough and sputum production with a later onset of |
| |wheezing, whereas the asthma patient with chronic obstruction gives a long history of wheezing with later onset of chronic |
| |productive cough. |
| | |
| | |
| | |
| |The patient with predominant bronchitis usually has an impressive history of cough and sputum production for many years with an |
| |immodest history of cigarette smoking. Initially the cough is present only in winter months, and the patient is apt to seek medical |
| |attention, if at all, only during the more severe of the frequent mucopurulent relapses. Over the years the cough progresses from |
| |hibernal to perennial and mucopurulent relapses increase in frequency, duration and severity. After beginning to experience |
| |exertional dyspnoea, the patient often seeks medical help and will be found to have a severe degree of obstruction. |
| | |
| | |
| | |
| |The development of exertional dyspnoea, often described as increased effort to breathe, heaviness, air hunger, or gasping, can be |
| |insidious. |
| | |
| | |
| | |
| |History, physical examination, and chest radiographs should be supplemented by tests of lung function performed during a |
| |symptomatically stable period. |
| | |
| |Ideally, complete spirometry, plethysmographic lung volumes, transfer of CO, arterial blood gases, and lung elastic recoil |
| |properties should be measured. |
| | |
|6.1.2 Corresponding Rubrics in the Complete Repertory: 5 |
|Symptom |Corresponding Rubrics |
|Chronic bronchitis is a condition associated with excessive tracheobronchial|Chest; inflammation; Bronchial tubes |
|mucus production sufficient to cause cough with expectoration for at least 3| |
|months of the year for more than 2 consecutive years. | |
| |Expectoration; copious; chronically |
| |Expectoration; copious; paroxysmal cough, after |
|Simple Chronic bronchitis describes a condition characterized by mucoid |Expectoration; mucous |
|sputum production. | |
| |Expectoration; mucous; translucent |
| |Expectoration; frothy |
| |Expectoration; easy |
| |Expectoration; transparent |
| |Expectoration, white |
| |Expectoration; difficult |
|Chronic mucopurulent bronchitis is characterized by persistent or recurrent |Expectoration; purulent |
|purulence of sputum in the absence of localized suppurative diseases such as| |
|bronchiectasis. | |
| |Expectoration; yellow |
| |Expectoration; thick |
| |Expectoration; lumpy |
| |Expectoration; balls, in shape of |
|Chronic bronchitis, a clinically defined condition with chronic cough and |Cough; chronic |
|phlegm. | |
| |Expectoration; constant, almost day and evening |
|The patient with chronic bronchitis with obstruction has a long history of |Expectoration; frequent |
|cough and sputum production with a later onset of wheezing, whereas the | |
|asthma patient with chronic obstruction gives a long history of wheezing | |
|with later onset of chronic productive cough. | |
| |Respiration; difficult; cough; with |
|The patient with predominant bronchitis usually has an impressive history of|Cough, winter |
|cough and sputum production for many years with an immodest history of | |
|cigarette smoking. Initially the cough is present only in winter months, and| |
|the patient is apt to seek medical attention, if at all, only during the | |
|more severe of the frequent mucopurulent relapses. Over the years the cough | |
|progresses from hibernal to perennial and mucopurulent relapses increase in | |
|frequency, duration and severity. After beginning to experience exertional | |
|dyspnoea, the patient often seeks medical help and will be found to have a | |
|severe degree of obstruction. | |
|The development of exertional dyspnoea, often described as increased effort | |
|to breathe, heaviness, air hunger, or gasping, can be insidious. | |
| |Respiration; difficult; exertion, after |
|The patient with predominant bronchitis is often overweight and cyanotic. |No rubric taken |
|There is apparently no apparent distress at rest, the respiratory rate is | |
|normal or only slightly increased, and there is no apparent usage of | |
|accessory muscles. | |
|Chest percussion note is normally resonant, and by auscultation one can |No rubric taken |
|usually hear coarse ronchi and wheezes that change in location and intensity| |
|after a deep and productive cough. | |
|6.1.3 RUBRICS TAKEN FOR REPERTORISATION:5 |
|Chest; inflammation; Bronchial tubes |Cough; chronic |
|Expectoration; copious; chronically |Cough, winter |
|Expectoration; constant, almost day and evening |Expectoration; copious; paroxysmal cough, after |
|Expectoration; frequent |Respiration; difficult; cough; with |
|Expectoration; mucous |Expectoration; mucous; translucent |
|Expectoration; frothy |Expectoration; easy |
|Expectoration; transparent |Expectoration, white |
|Expectoration; purulent |Expectoration; difficult |
|Expectoration; yellow |Expectoration; thick |
|Expectoration; lumpy |Expectoration; balls, in shape of |
|Respiration; difficult; exertion, after | |
|6.1.4 Repertorisation chart (using Complete Repertory By Roger van Zandvoort: 5 |
| |
|The following drugs will be tried during the study: |
| Stannum metallicum, | Arsenicum album, |Silicea, |
|Phosphorus, |Lycopodium |Pulsatilla. |
| Calcarea carb, |Sulphur, |Hepar sulph, |
| Ipecacuanha |Bryonia alba, | Antimonium tartaricum |
| Carbo vegetables, | Spongia tosta, | |
|6.1.7 Prescribing indications of the medicines on trial 6 |
|No. |MEDICINE |RUBRICS |CHARACTERISTIC SYMPTOMS |
| | | | |
|01. |Stannum |Chest; inflammation; Bronchial tubes |It is especially suited to persons who have long |
| |metallicum |Expectoration; copious; chronically |been g rowing feeble. There is increasing |
| |(40/16) |Respiration; difficult; cough; with |weakness, cachexia with : sallow waxy countenance |
| | |Expectoration; mucous |and dark rings under the eyes. |
| | |Expectoration; easy |Pain begins lightly and increases gradually to the |
| | |Expectoration; difficult |highest point and then gradually declines in the |
| | |Expectoration; yellow |same manner as it appeared. |
| | | | |
| | |Expectoration; balls, in shape of |There is GREAT DEBILITY and profound weakness which|
| | | |is the key note of Stannum. It is marked both |
| | |Cough, winter |mentally and bodily. The chest is so weak that |
| | |Expectoration; frequent |she drops into a chair instead of sitting down. |
| | |Expectoration; transparent | |
| | |Expectoration, white |Feels weak and faints especially when going |
| | |Expectoration; purulent |downstairs. Can go up well enough. Nausea and |
| | |Expectoration; thick |vomiting from the odour of cooking food. |
| | |Expectoration; lumpy | |
| | |Respiration; difficult; exertion, after |Empty, sinking all-gone sensation in chest and |
| | | |stomach |
| | | |Sweetish and salty expectoration and taste in |
| | | |mouth. |
| | | |The patient experiences very debilitating sweat |
| | | |after 4 a.m. |
| | | |The patient is sad, despondent, feels like crying |
| | | |all the time, but crying makes her worse. |
| | | |Yellowishness is the nature of discharges. |
| | | |Mentally the patient is very much sad and |
| | | |despondent. |
| | | |Great sadness strong disinclination to talk and a |
| | | |pronounced aversion to the company of men. |
| | | |Continued restlessness with anxiety. |
| | | |Distress of mind ceases as soon as menses begin to |
| | | |flow. |
| | | |Mental symptoms are caused by emotion, fright, etc.|
|02. |Arsenicum album|Chest; inflammation; Bronchial tubes |The patient is lean, thin, debilitated having |
| |(37/16) |Expectoration; copious; chronically |Hippocratic face dirty and waxy look of the skin . |
| | |Respiration; difficult; cough; with |Very fastidious. \wants everything neat, clean and |
| | |Expectoration; mucous |in order. |
| | |Expectoration; mucous; tanslucent |Chilly patient. There is internal chilliness and |
| | |Expectoration; frothy |so the patient craves heat, excepting in outer |
| | |Respiration; difficult; exertion, after |head. |
| | | |Arsenic patient has GREAT FEAR OF DEATH. |
| | |Expectoration; transparent |Mentally restless, but physically too |
| | |Expectoration, white |weak and exhausted to move about. |
| | |Expectoration; purulent |Burning pain relieved by heat except in head. |
| | |Expectoration; difficult |Great prostration is persistently present, sinking|
| | |Expectoration; yellow |of strength out of proportion to a degree of |
| | | |illness. |
| | |Expectoration; thick |Gastric derangements such as diarrhoea, vomiting, |
| | |Expectoration; lumpy |etc., are due to food poisoning from spoiled eggs, |
| | |Expectoration; balls, in shape of |fish or meat, decayed food, alcohol, ice cream, |
| | | |etc. |
| | |Cough, winter |Complaints return periodically (usually annually) |
| | | |All discharges are acrid, scanty, putrid, dark and |
| | | |offensive with cadaverous odour |
| | | |Thirst for small quantity of water at short |
| | | |intervals in acute states but in chronic state |
| | | |there is no thirst. |
| | | |Cannot bear the smell or sight of food. |
| | | |All symptoms are aggravated at MID-DAY AND |
| | | |MID-NIGHT. |
| | | | |
| | | | |
|03. |Silicea |Chest; inflammation; Bronchial tubes |Very nervous, excitable temperament. Lack of |
| |(35/17) |Expectoration; copious; chronically |stamina and very much afraid of failure. Very |
| | |Expectoration; mucous |sensitive to all impressions. WANT OF GRIT, both |
| | |Expectoration; purulent |mental and physical. |
| | |Expectoration; yellow |Fixed ideas. Has got pin mania, especially for |
| | |Expectoration; thick |babies. Thinks of nothing except pins; he fears |
| | |Expectoration; lumpy |them, still searches for them and counts and |
| | |Expectoration; balls, in shape of |preserves them with great care. Headstrong and |
| | | |obstinate babies who cry when kindly spoken to. |
| | |Respiration; difficult; cough; with | |
| | |Expectoration; transparent |Ailments from: Vaccination, suppressed foot-sweat, |
| | | |exposure to draught of air. Chest complaints of |
| | |Respiration; difficult; exertion, after |stone cutters. |
| | | | |
| | |Cough; chronic |Highly Chilly patient. Wraps himself up with warm |
| | |Expectoration; frequent |clothing even in hot summer weather. |
| | |Expectoration; mucous; tanslucent |Every little injury suppurates. |
| | |Expectoration; frothy |Has got a wonderful CONTROL OVER THE SUPPURATIVE |
| | |Expectoration; easy |PROCESSES, anywhere and everywhere in the body. |
| | |Expectoration; white |Constitution which suffers from deficient nutrition|
| | | |from defective assimilation. |
| | | |Very sensitive to all impressions, especially noise|
| | | |and becomes anxious there from. |
| | | |Obstinate constipation; stool hard and knotty. When|
| | | |PARTLY EXPELLED RECEDES BACK. |
| | | |Night-walking. Gets up while asleep, walks about |
| | | |and lies down again – all quite unconsciously. |
| | | |Desire for cold drinks, cold food, ice cream. Wants|
| | | |to be magnetized. |
| | | |Sweat of hands, toes, feet, axillae is VERY |
| | | |OFFENSIVE. Intolerable, sour, carrion-like odour of|
| | | |feet, without perspiration and every evening. |
|04. |Phosphorus |Chest; inflammation; Bronchial tubes |Phosphorus is best suited for tall, slender persons|
| |(34/14) |Expectoration; copious; chronically |with narrow chest. Young people who grow too |
| | |Respiration; difficult; cough; with |rapidly and are incline to stoop. |
| | |Expectoration; mucous |Sanguine temperament, possessing quick perception |
| | |Expectoration; transparent Expectoration, white |and very sensitive nature; also having bilious, |
| | |Expectoration; purulent |irritable temperament. |
| | |Expectoration; yellow |Chilly patient, its head and stomach crave cold, |
| | | |cold application, cold food and COLD DRINKS. |
| | | | |
| | |Cough; chronic |Burning anywhere and everywhere all over the body. |
| | |Expectoration; frothy |Burning in spots along the spine, between the |
| | |Expectoration; difficult |scapulae, of palm and hands, in chest. |
| | |Respiration; difficult; exertion, after |A weak, empty all gone sensation in head, chest, |
| | | |stomach and entire abdomen. |
| | |Expectoration; thick |Craving cold thins, ice-creak which agrees; cold |
| | |Expectoration; lumpy |water which is thrown up as soon as it gets warm in|
| | | |the stomach. Aversion to tobacco, sweets tea, |
| | | |pudding, coffee and beer. |
| | | |Oversensitiveness. Light, noise, odour, touch, |
| | | |electric changes, thunderstorms. |
| | | |Disinclination to both mental and physical exertion|
| | | |even to study or to converse. |
| | | |Restlessness. Cannot stand still for a moment, |
| | | |with CONSTANT FIDGETY FEELING ALL OVER BODY, |
| | | |especially in evening, at twilight. Restlessness |
| | | |with anxiety. |
| | | |Most of the complaints are aggravated when lying on|
| | | |left side. |
| | | |Swelling of both the eyelids. |
| | | |Mind. The patient is very much apathetic and |
| | | |indifferent to friends and surroundings, unwilling |
| | | |to talk, thinks slowly, moves sluggishly. |
| | | |Patient is quite intelligent, but physically weak. |
| | | |There is great fear in darkness. Fear of death |
| | | |when alone. |
| | | |Mental exertion, strong emotion, strong odours, gas|
| | | |vapours, thunderstorm, lightning, loss of vital |
| | | |fluids, exposure to drenching rain, tobacco by |
| | | |washing clothes, having hair cut; excessive use of |
| | | |table salt |
|05 |Lycopodium |Chest; inflammation; Bronchial tubes |Patient is tired; Chronic mental fatigue. |
| |(29/14) |Expectoration, white |Dread of appearing in public. |
| | |Expectoration; purulent |Desire to be alone; yet has dread of solitude. |
| | |Respiration; difficult; exertion, after |Great anticipation: lack of confidence, weakness of|
| | |Expectoration; mucous |memory; confused thoughts; loss of confidence in |
| | |Expectoration; yellow |himself. |
| | | |Easily angered; cannot endure opposition or |
| | |Respiration; difficult; cough; with |contradiction. Seeks dispute. |
| | |Expectoration; difficult |Greedy and miserly, malicious, avaricious and |
| | |Expectoration; thick |pusillanimous; very much sensitive; even cries when|
| | | |thanked. |
| | |Cough; chronic |FOR PERSONS INTELLECTUALLY KEEN BUT PHYSICALLY |
| | |Expectoration; copious; chronically |WEAK. |
| | |Expectoration; frequent | |
| | |Expectoration; lumpy |Ailments from: Fright, anger, mortification or |
| | |Expectoration; balls, in shape of |vexation with reserved displeasure. |
| | | | |
| | | |RIGHT SIDED REMEDY. |
| | | |Suited for deep, chronic, progressive diseases. |
| | | |Nearly all the diseases are WORSE IN THE AFTERNOON |
| | | |4 TO 8 PM. |
| | | |Sourness of the discharges. Everything tastes sour,|
| | | |e.g. eructation. Heartburn, waterbrash, sour |
| | | |vomiting. |
| | | |Intolerance of cold drinks; craves everything warm.|
| | | |Desire for sweet things: warmfood and drink. |
| | | |Aversion to tobacco, bread, coffee. |
| | | |Canine hunger, but a few mouthfuls fill up to the |
| | | |throat. |
| | | |Acidity, wine and bloating of abdomen, especially |
| | | |the lower abdomen. |
| | | |Red sand in urine. Child cries before urinating. |
| | | |Fan like movement of alae-nasi.occuring in cerebral|
| | | |and abdominal complaints. |
| | | |Half open condition of the eyes during sleep. |
| | | |Right foot hot and left cold. |
| | | |Dryness of parts such as vagina and skin especially|
| | | |palms. |
|06. |Pulsatilla | |The patient is mild, gentle, amiable in character, |
| |(29/14) |Chest; inflammation; Bronchial tubes |yielding disposition, but sometimes timid too. |
| | |Expectoration; copious; chronically |Changeability of mental conditions runs through the|
| | |Respiration; difficult; cough; with |whole drug. |
| | |Expectoration; mucous |Weeping disposition. The patient is always full of |
| | |Expectoration; easy |tears. So she cannot relate her complaints without |
| | |Expectoration; difficult |weeping. |
| | |Expectoration; yellow |Hypochondriacal moroseness; takes bad side of |
| | | |everything. |
| | |Expectoration; balls, in shape of |Consolation: gives her immense comfort and relief. |
| | | |Highly emotional, afraid in the evening, fears to |
| | |Cough, winter |be alone. Fear of darkness and of ghosts. Morbid |
| | |Expectoration; frequent |fear of meeting the opposite sex. |
| | |Expectoration; transparent | |
| | |Expectoration, white |Ailments from: Chill getting feet wet; eating fatty|
| | |Expectoration; purulent |and starchy food; ice cream; tea and coffee, abuse |
| | |Expectoration; thick |of mercury, quinine, sulphur, chamomile, abortion, |
| | |Expectoration; lumpy |irregular menses; ovarian and uterine troubles; |
| | |Respiration; difficult; exertion, after |worm affection in children and indigestion. |
| | | | |
| | | |Changeability of symptoms. |
| | | |Chilliness. |
| | | |Thirstlessness. |
| | | |Desire: for open air, fatty food. Disagrees meat, |
| | | |bread, milk and smoking. |
| | | |Aggravation from warm in general and amelioration |
| | | |from cold in general and from open air. |
|07. |Calcarea Carb. |Expectoration; copious; chronically |Great apprehension, worsening towards evening. |
| |(26/12) |Expectoration; mucous |Fear of darkness, loss of reason, misfortune, |
| | |Expectoration; purulent |contagious and chronic disease. Fears that she will|
| | |Expectoration; yellow |lose her reason or that people will observe her |
| | |Respiration; difficult; exertion, after |mental confusion. Very forgetful, confused and low |
| | | |spirited. Dejected and melancholic. Great anguish |
| | |Chest; inflammation; Bronchial tubes |with palpitation. Restlessness of mind with gloomy |
| | |Expectoration, white |mood and anxiety. Peevish, always obstinate and |
| | |Expectoration; difficult |self-willed. Indisposed to all work. Sight mental |
| | | |effort produces heat. Timid and restless, as if an |
| | |Expectoration; thick |evil was impending over her. Solitude is a burden |
| | | |to her with coldness of face, of hands and feet. |
| | |Respiration; difficult; cough; with |Great desire to be magnetized. |
| | |Expectoration; frothy | |
| | |Expectoration; balls, in shape of |Ailments from: Defective assimilation, imperfect |
| | | |ossification, suppressed sweat, alcohol, cold moist|
| | | |wind, self-abuse, over lifting, strains, mental |
| | | |strains. Loss of vital fluids, suppressed eruption,|
| | | |suppressed menses, Suppressed foot-sweat, fright, |
| | | |etc. |
| | | | |
| | | |GREAT SENSITIVENESS TO TAKE COLD; CANNOT TOLERATE |
| | | |COLD. |
| | | |Disposed to grow fat. |
| | | |HEAD SWEATS PROFUSELY, WHILE SLEEPING WETTING the |
| | | |pillow far around. Sweat of single parts, Sour |
| | | |Smelling. |
| | | |Coldness in general and the single part. |
| | | |Feels better in every way when constipated. |
| | | |Likes to be magnetized. |
| | | |All discharges smell sour. |
| | | |Longing for eggs, craves undigestible things; has |
| | | |aversion to meat; great longing for fresh air. |
| | | | |
|08. |Sulphur |Expectoration; copious; chronically |Sulphur is especially suited to lean, |
| |(25/18) | |stoop-shouldered persons who walk and sit stooping,|
| | |Chest; inflammation; Bronchial tubes |walk stooping like an old man. STANDING IS THE |
| | |Expectoration, white |WORSE POSITION FOR A SULPHUR PATIENT. |
| | |Expectoration; yellow |Dirty, filthy look of the body, prone to skin |
| | |Respiration; difficult; exertion, after |affections have redness of all the external |
| | | |orifices. |
| | |Cough; chronic |Patient is very much sensitive to atmospheric |
| | |Expectoration; copious; paroxysmal cough, after |changes. He is accepted as a HOT PATIENT. |
| | |Expectoration; frequent | |
| | |Respiration; difficult; cough; with | |
| | |Expectoration; mucous | |
| | |Expectoration; frothy | |
| | |Expectoration; easy | |
| | |Expectoration; transparent | |
| | |Expectoration; purulent | |
| | |Expectoration; difficult | |
| | |Expectoration; thick | |
| | |Expectoration; lumpy | |
| | |Expectoration; balls, in shape of | |
|9. |Hepar |Chest; inflammation; Bronchial tubes |GREAT IRRITABILITY, OVERSENSITIVENESS AND |
| |sulph(25/12) |Expectoration; mucous |HYPERSENSITIVENESS. |
| | |Expectoration; yellow |Suited to torpid lymphatic constitution, persons |
| | |Expectoration; thick |with light hair and complexion; muscles are soft |
| | | |and flabby. Irritable temperament: easily excited,|
| | |Expectoration; frequent |slightest cause irritates the patient. Highly |
| | |Respiration; difficult; cough; with |chilly patient. |
| | |Expectoration; thick |Very sensitive to touch. HYPERSENSITIVENESS to |
| | |Expectoration; lumpy |touch. |
| | |Expectoration; difficult |Sweat profusely day and night without any relief, |
| | | |which is sour and offensive. |
| | | |Sensation of a splinter, fish bone or plug in |
| | |Expectoration frothy |throat. |
| | |Expectoration; easy |All the discharges are very much sour. |
| | |Expectoration; purulent |Aggravation From COLD IN GENERAL, cold air, cold |
| | | |food, uncovering. Amelioration: From WARMTH IN |
| | | |GENERAL; covering from head to foot, from warm food|
| | | |and drink; IN DAMP WET WEATHER. |
| | | |The patient has great CRAVING for sour things, |
| | | |vinegar, wine, acids and strong tasting foods. |
| | | |AVESION to fatty food; |
| | | |dislike for all kinds of nourishment |
|10. |Ipecacuanha |Chest; in Chest; inflammation; Bronchial tubes |Most of its acute complaints commence with nausea |
| |(20/12) |Respiration; difficult; cough; with |and vomiting or all complaints requiring Ipecac |
| | |Expectoration; difficult |are attended more or less with nausea. |
| | |Respiration; difficult; exertion, after |Nausea constant, continuous and persistent with or |
| | | |without vomiting. Nausea not relieved by vomiting. |
| | | |Thirstlessness runs through the whole drug. Clean |
| | |Cough, winter |tongue, with much saliva, but no thirst. |
| | |Expectoration; mucous |Bright red haemorrhage from natural orifices like |
| | |Expectoration frothy |nostrils, mouth and especially from uterus. |
| | |Expectoration; easy |Cold sweat on forehead |
| | |Expectoration, white |Desire for sweets and dainties. |
| | |Expectoration; purulent | |
| | |Expectoration; yellow | |
| | |Expectoration; thick | |
| | | | |
|11. |Bryonia |Chest; inflammation; Bronchial tubes |Tall slender persons having dark hair, dark |
| |(16/13) |Expectoration; mucous |complexion, and firm muscular fibres. |
| | | |Irritable temperament. |
| | |Expectoration; copious; chronically |Patients are hot; aggravated by warmth in general. |
| | | |Rheumatic and gouty diathesis. |
| | |Cough, winter |All complaints are worse from motion. WITH |
| | |Respiration; difficult; cough; with |AMELIORATION BY ABSOLUTE REST AND PRESSURE. |
| | |Expectoration; frothy |It is a very persistent remedy. All complaints |
| | |Expectoration; transparent |develop slowly and have an insidious beginning. |
| | |Expectoration, white |Bryonia causes dryness of all the mucus membranes |
| | |Expectoration; purulent |e.g. lips, mouth, nose, respiratory tract, |
| | |Expectoration; difficult |alimentary tract and thereby. |
| | |Expectoration; yellow |Great thirst for large quantity of cold water at |
| | | |long intervals; great appetite, eats varaciously. |
| | |Expectoration; thick |Stitching pain runs through the whole of Bryonia |
| | |Expectoration; lumpy |which is relieved by absolute rest and pressure and|
| | | |by lying on painful side. |
| | | |Dropsical effusion into the serous and synovial |
| | | |membrerane, resulting in pleurisy, rheumatic |
| | | |arthritis etc. |
| | | |Desires for things, which when offered are |
| | | |immediately refused. Oysters, sweets, coffee, cold |
| | | |acid drinks and sour drink. To milk, rich food, |
| | | |fatty and greasy food. |
| | | |Most complaints aggravate in summer and by heat; |
| | | |symptoms aggravate after a meal. |
| | | |There is intolerance of vegetable food. |
| | | |Nose-bleed when menses should appear; |
| | | |blood-spitting or haemoptysis. |
| | | |Breasts are heavy, of a stony hardness, pale but |
| | | |hard, hot and painful; MUST SUPPORT THEM WITH HAND |
| | | |TO prevent least motion. |
| | | |Mind. The patient is very morose and ill-humoured;|
| | | |exceedingly irritable and inclined to be angry. |
| | | |There are great anxiety and mental depression. |
| | | |Delirium, talks about daily business; worse at |
| | | |night; desires to escape from bed and wants to go |
| | | |home, although the patient is at home. Constant |
| | | |motion of the left arm and leg. Desires for things|
| | | |which are refused when offered. Weakness of mind, |
| | | |as if the would faint. |
| | | |Ailments from - Anger, chagrin, mortification; |
| | | |complaints after taking cold or getting hot in |
| | | |summer; when the days are hot and nights are cold; |
| | | |cold food and drink; from suppression of discharges|
| | | |and skin eruptions. |
|12. |Antim tart |Chest; inflammation; Bronchial tubes |Hydrogenoid constitution . |
| |(16/11) |Respiration; difficult; cough; with |Usually suited for diseases originating from |
| | | |exposure to damp basements or cellars, and after |
| | |Cough; chronic |vaccination. |
| | |Expectoration; mucous |There is great accumulation of mucus in air passage|
| | |Expectoration; purulent |which cannot be coughed out, but gives a rattling |
| | | |sound, popularly known as “Death Rattle”. |
| | |Cough, winter |Face become pale, cyanosed and flushed due to |
| | |Expectoration; frothy |circulation of unoxydised blood. |
| | |Expectoration; easy |Nausea. Vomiting, coldness and prostration run |
| | |Expectoration; transparent |through. |
| | |Expectoration, white |IRRESISTIBLE DESIRE TO SLEEP. |
| | |Expectoration; difficult |Craving for apples and acids. Aversion to mild and|
| | |Expectoration; thick |tobacco. |
| | | |Pneumonia with jaundice. |
| | | |Bad effects of vaccination, when Thuja fails and |
| | | |Silicea. |
| | | |Pustular eruption like small pox is a great |
| | | |symptoms. |
| | | |Mind. Confusion of head with a feeling as if he |
| | | |must sleep. Child will not allow ilself to be |
| | | |touched. Bad humour during bronchial catarrh. |
| | | |Apprehension and restlessness during evening. |
| | | |Dread of being left alone. Mental excitement and |
| | | |nervousness. The patient is frightened at night. |
| | | |Vertigo on closing the eyes, when walking and |
| | | |flickering before the eyes. |
|14 |Carbo |Expectoration; copious; chronically |Persons of advanced age, women at turn of life; |
| |vegetabilis(20/| |prematurely old people. Cachetic persons, young or|
| |11) | |old. The face is puffy, bluish, pale and |
| | |Chest; inflammation; Bronchial tubes |Hippocratic with cold sweat. |
| | |Respiration; difficult; cough; with |Though the body is cold to touch, the patient WANTS|
| | |Expectoration; mucous |constantly ato be FANNED RAPIDLY AND FROM NEAR. |
| | |Expectoration, white |HAEMORRHAGIC DIATHESIS. Passive haemorrhage of |
| | |Expectoration; yellow |black or dark blood from every orifice of the body |
| | |Respiration; difficult; exertion, after |e.g. bleeding from lung, bladder, uterus, stomach, |
| | | |ulcers, etc. resulting from weakened circulation. |
| | |Expectoration; easy |Haemorrhagic tendency runs through the whole |
| | |Expectoration; purulent |remedy. |
| | |Expectoration; thick |Exhausted vitality from loss of vital fluid. |
| | |Expectoration; lumpy |Surface of the body is COLD TO TOUCH, especially |
| | | |from knee to feet. The pulse is intermittent, |
| | | |thready and imperceptible. |
| | | |Weak Digestion, SIMPLE FOOD DISAGREES causing |
| | | |excessive flatulence; abdomen is full to bursting |
| | | |point especially on the upper part; aggravation |
| | | |from least food and relief from eructation and on |
| | | |passing flatus. |
| | | |In the last stage of any disease with copious cold |
| | | |sweat, cold breath, cold tongue, voice lost, this |
| | | |remedy may save a life. |
| | | |WANTS TO BE FANNED RAPIDLY AND FROM A CLOSE |
| | | |DISTANCE in nearly every complaint. |
| | | |Wants clothing loose around the abdomen. |
| | | |The patient craves, things which makes him sick. |
| | | |Whisky or brandy. |
| | | |Hoarseness aggravated in the evening. |
| | | |Sump toms of imperfect oxidation, resulting from |
| | | |deficient capillary circulation, causing blueness |
| | | |of skin and coldness of extremities. |
| | | |Constant sour and rancid eructation. |
| | | |Slowness of though and weakness of memory, dislikes|
| | | |darkness and fears ghosts. |
| | | |Loss of vital fluid, memory, salt, salted meat or |
| | | |fish from abuse of quinine, especially suppressed |
| | | |chill and fever; bad effects of long ago injury, |
| | | |persons who have never fully recovered from the bad|
| | | |effects of some previous illness. |
|14. |Spongia |Chest; inflammation; Bronchial tubes |Exhaustion and heaviness of the body after slight |
| |(14/08) |Respiration; difficult; exertion, after |exertion, with orgasm of blood to chest, face. |
| | | |Anxiety and difficult breathing. |
| | |Cough; chronic |Anxiety and fear. Every excitement increases the |
| | |Expectoration; mucous |cough. |
| | |Expectoration, white |Great dryness of all air-passages. Hoarseness; |
| | |Expectoration; yellow |larynx dry, burns, constricted. Cough,. Dry |
| | | |barking, croupy; larynx sensitive to touch. Croup;|
| | |Respiration; difficult; cough; with |worse, during inspiration and before midnight. |
| | |Expectoration; difficult |Respiration short, panting, difficult; feeling of a|
| | |Expectoration; lumpy |plug in larynx. Cough abates after eating or |
| | | |drinking, especially warm drinks. |
| | | |Chest weak; can scarcely talk. |
| | | |Bronchial catarrh, with wheezing, asthmatic cough, |
| | | |worse cold air, with profuse expectoration and |
| | | |suffocation; worse, lying with head low and in hot |
| | | |room. Oppression and heat of chest, with sudden |
| | | |weakness. |
|Selection of Medicine |
|Selection of medicine will be made out of the 14 medicines taken up for clinical trial. The first prescription from amongst these 14 medicines |
|shall be the medicine that fetches the highest value on repertorisation of t he presenting signs and symptoms of the disease and its selection |
|shall be further guided by the characteristic mental/emotional and physical attributes of the patient and concomitant(s), if any. |
|Cases which need medicine(s)other than trial group of medicines will be treated in the general OPD and not included in the study. A separate |
|record of such cases will however be maintained at the center. |
|6.2.1 |In case of chronic state |
| |Basis of Selection of Medicine: |
| | |
| |Selection of medicine will be made out of the 14 trial medicines, to be guided by the totality of presenting signs and |
| |symptoms on the basis of ‘Principle of Similia’. |
| |A comprehensive case record on the specially evolved case recording proforma will be maintained Form C1. Care will be taken |
| |to record the following: |
| |Detailed evolution of the complaints. |
| |Careful analysis of the characteristic nature of the symptoms |
| |First prescription: |
| |This will constitute of single dose of indicated medicine in potency 30, 4 pills (size 30), to be taken by the patient on |
| |empty stomach, and followed by placebo, next day onwards, three times a day for two weeks. |
| |Selection of Potency |
| | |
| |This will constitute of single dose of indicated medicine in potency 30, to be |
| |taken by the patient on empty stomach. |
| |Dose |
| | |
| |Each Dose of indicated medicine will consist of, 4 pills size 30. |
| |Repetition |
| | |
| |Indicated medicine will not be repeated. |
| |Follow up (Change of Medicine / Second Prescription) |
| |Participants will be followed for assessment as per Form D. Response of the prescription will be assessed and further treatment |
| |will be as per following guidelines: |
| | |
| |A. In case of amelioration: |
| | |
| |If improvement continues → Placebo to continue. |
| |If improvement stops → Repeat the medicine (first prescription) in the same potency. |
| |If no further amelioration occurs even after medicine given in same potency or improvement lasts for a very short period → Give |
| |higher potency of same medicine. |
| |If amelioration of presenting complaints is accompanied by appearance of old symptoms → continue placebo till the improvement |
| |continues. |
| |If old symptoms come back to stay → repeat same medicine in same potency and then followed as in (iii) above. In case there is no |
| |perceptible improvement after adequate repetition of medicine in different potencies, change of medicine is to be considered |
| | |
| |B. In case of aggravation: |
| | |
| |Increase in baseline symptoms |
| |Short aggravation followed by consistent amelioration (homoeopathic aggravation):→ Continue placebo. |
| |Aggravation of same symptoms without any relief: |
| |If intensity is mild → wait for another week, and if no improvement follows or worsening occurs after one week, change of medicine|
| |is to be considered. |
| |If intensity is severe → the case to be treated as an acute exacerbation of chronic disease. |
| | |
| |Appearance of new symptoms |
| |If new symptoms are mild and do not cause much concern to the patient → placebo will be continued for one week. |
| | |
| |If no improvement follows or worsening occurs after one week → change of medicine is to be considered. |
| | |
| |If these new symptoms are severe and cause considerable discomfort to patient → change of medicine is to be considered. |
| | |
| |C. In case of no change after first or subsequent prescriptions: |
| | |
| |In case there is no perceptible change (either worse or better) after 1 week of administration of medicine →one dose of the same |
| |medicine to be repeated in higher potency (200 and 1M in succession whenever no response from 200) 4 pills, size no.30, taken over|
| |the tongue, followed by placebo for one week. |
| | |
| |In case there is no perceptible improvement after adequate repetition of medicine in different potencies, the investigator must |
| |look for any obstacle(s) to cure and steps may be taken to remove them. A record of such advice followed by the patient is to be |
| |kept in the case follow up. In case no such obstacle(s) found, change of medicine is to be considered on the same line as |
| |mentioned in the footnote. |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |------------------------------------------------------------------------------------------------------------------- |
| |If aggravation/ no change still continues, another medicine on the basis of modified picture of the disease is to be considered. |
| |In case aggravation continues or no improvement comes up inspite of changing medicine twice, the case is to be closed from study |
| |and declared as clinical failure |
|6.2.2 |In case of acute exacerbation of chronic disease or any other acute disease arising during the course of treatment of chronic |
| |disease. |
| |6.2.2.1. Basis of Selection of Medicine: |
| |Prescription will be based on the characteristic symptoms modified as a consequence of acute disease. The medicine selected will |
| |be either a continuation of the pre-selected medicine, or one of the better indicated trial medicine, or a new remedy which may|
| |be worked out for acute totality. |
| |6.2.2.2 Selection of Potency: |
| |Medicine for the treatment of acute exacerbation shall be given in 6 potency. |
| |6.2.2.3 Dose |
| |Each Dose of indicated medicine will consist of, 4 pills size 30. |
| |6.2.2.4 Repetition |
| |Indicated medicine will be repeated few minutes to hours depending on the intensity of the symptoms till perceptible change appears |
| |(Improvement of signs and symptoms). Appearance of any change will be immediately followed by placebo/ or change in remedy, according|
| |to response. |
| |6.2.1.5. Follow up (change of medicine / second prescription) |
| |Follow up will be done frequently (at an interval of 1-3 days) depending on the need, till such time the acute condition subsides |
| |after judicious treatment. Response of the prescription will be assessed and further treatment will be as per following guidelines: |
| | |
| |A. In case of amelioration of presenting sign & symptoms: |
| | |
| |If improvement continues → Placebo to continue. |
| | |
| |If improvement stops and case presents with same symptomatology → Repeat the same medicine (first prescription) in the higher |
| |potency. i.e. 30 if needed. |
| | |
| |If case presents with different symptomatology → change of medicine; another indicated medicine from amongst Trial Medicines in 6 |
| |potency on the same guidelines as for the first prescription. |
| | |
| |In case of aggravation of presenting sign & symptoms: |
| |(i) Increase in baseline symptoms |
| |Short aggravation followed by consistent amelioration (homoeopathic aggravation):→ Continue placebo. |
| | |
| |Aggravation of same symptoms without any relief: |
| |If intensity is mild → wait for few hours’ and if no improvement follows or worsening occurs, change of medicine is to be considered.|
| | |
| |If intensity is severe →To be withdrawn from the study and to be referred for appropriate medical care. |
| | |
| |(ii) Appearance of new symptoms |
| |If new symptoms are mild and do not cause much concern to the patient → placebo will be continued. |
| | |
| |If no improvement follows or worsening occurs → change of medicine; another indicated medicine from amongst Trial Medicines in 6 |
| |potency on the same guidelines as for the first prescription. |
| | |
| |If these new symptoms are severe and cause considerable discomfort to patient → change of medicine; another indicated medicine from |
| |amongst Trial Medicines in 6 potency on the same guidelines as for the first prescription. |
| | |
| |If the medicine indicated for change of prescription at any stage does not lies in the trial group of medicines, the case will |
| |excluded from study. |
| |In case of no change after first or subsequent prescriptions: |
| |In case there is no perceptible change (either worse or better i.e. change in FDI) on next day or after few hours of |
| |administration of medicine →one dose of the same medicine in higher potency is to be repeated followed by placebo. |
| |In case there is no perceptible improvement after adequate repetition of medicine,[the investigator must look for any obstacle(s) |
| |to cure and steps may be taken to remove them. A record of such advice followed by the patient is to be kept in the case follow |
| |up. In case no such obstacle(s) are found, change of medicine is to be considered on the same line as mentioned in the footnote. |
| | |
| |Efforts would be made to ensure compliance of Instructions and adherence to the prescribed therapeutic schedule. In case of |
| |deviation, valid justification should be recorded. |
| | |
| |Foot note ; If aggravation/ no change in 1 day or early, depending on intensity , another medicine on the basis of modified |
| |picture of the disease is to be considered from 13 trial medicine. In case aggravation continues or no improvement comes up even |
| |after a maximum of three indicated medicines have been tried and no improvement occurs, the case is to be closed from study and |
| |declared as clinical failure. Such patients will be referred and will be treated according to the practice of the |
| |hospital/institute. |
| | |
| |Treatment of chronic disease after the acute exacerbation/acute disease subsides is to be made depending on the state of signs/ |
| |symptoms of the chronic disease i.e. the indicated medicine in suitable potency will be given only on the appearance of the |
| |chronic state and placebo to be continued till such time that there is amelioration of the chronic disease. Case will be followed |
| |up as per approach towards chronic case. |
| | |6.2.3. | Source of Medicines for Trial |
| | | |Homoeopathic medicines for the trial would be procured from the SBL Private Ltd. Sahibabad, Ghaziabad, |
| | | |Uttar Pradesh. |
| | |6.2.4 |Change of therapy |
| | | |The change of therapy or the second prescription shall be made in accordance with the guidelines |
| | | |mentioned for the second prescription above(4.5.2.2) |
| | |6.2.5 |General supportive care |
| | | |Intelligent management must be based on as complete knowledge as possible of the degree of obstruction, |
| | | |the extent of disability, and the relative reversibility of the patient’s illness. After the initial |
| | | |assessment, the physician has some idea of the relative emphasis to be placed on patient education, |
| | | |rehabilitative and preventive measures, and direct therapeutic interventions in management of the patient|
| | | |and the illness. |
| | | |Smoking |
| | | |Cigarette smoking is the most commonly identified correlate with both chronic bronchitis during life and |
| | | |extent of emphysema at postmortem. |
| | | |Passive exposure to tobacco smoke correlates with respiratory symptoms such as cough, wheeze, and sputum |
| | | |production. |
| | | |The physician should always ask the patient about smoking, urge the patient to stop smoking, help the |
| | | |patient set a date to stop, and provide close follow up support for the patient’s efforts. |
| | | | |
| | | |Environment (Air-pollution) & Occupation |
| | | |The incidence and mortality rates of both chronic bronchitis and emphysema may be higher in heavily |
| | | |industrialized urban areas. Exacerbations of bronchitis are clearly related to periods of heavy pollution|
| | | |with sulfur dioxide (SO2) and particulate matter. |
| | | |Chronic bronchitis is more prevalent in workers who engage in occupations exposing them to either |
| | | |inorganic or organic dusts or to noxious gases. Epidemiological surveys have succeeded in demonstrating |
| | | |an accelerated decline in lung function in many such workers --- e.g., workers in plastic plants exposed |
| | | |to toluene diisocyanate, and carding room workers in cotton mills --- suggesting that their occupational |
| | | |exposure contributes to their future disability. |
| | | |In patients in whom occupational or environmental exposures are thought to play a significant role, |
| | | |change of occupation or relocation of dwelling is advisable. A simple environmental change is that of |
| | | |eliminating aerosol sprays such as deodorants, hair sprays, and insecticides from the household. Hair |
| | | |sprays have been shown to produce acute airways responses even in normal subjects. |
| | | |Exercise |
| | | |Exercise programmes although not accompanied by measurable improvement in lung function, result in |
| | | |increased exercise tolerance and an improved sense of well-being. The improvement is usually |
| | | |task-specific, so most physicians advise walking in preference to the use of special apparatus, such as |
| | | |stationary bicycles. |
| | | |Nutrition |
| | | |If malnutrition (body weight less than 85 percent of ideal) is present, oral dietary supplements can |
| | | |result in improved muscle strength, less fatigability, and lessening of breathlessness. |
| | | |Respiratory infections |
| | | |Morbidity, mortality and frequency of acute respiratory illnesses are higher in patients with chronic |
| | | |bronchitis. Many attempts have been made to relate these illnesses to infection with viruses, myoplasmas,|
| | | |and bacteria. However, only the rhinovirus are found just as often between as during exacerbations. |
| | | |Infections cannot be totally avoided, and the patient should be made aware that increasing purulence, |
| | | |viscosity, or volume of secretions signals the onset of an infection, which should be treated early. |
| | | |Microscopic examination and culture of sputum are indicated if there are chills, fever or chest pain. |
| | | |Familial factors |
| | | |Familial aggregation of chronic bronchitis has been well documented. Children of smoking parents may |
| | | |experience more frequent and severe respiratory illnesses and have a higher prevalence of chronic |
| | | |respiratory symptoms. In addition, nonsmokers who remain in the presence of cigarette smokers (passive |
| | | |smokers) have increased blood levels of carbon monoxide, which indicate that they are significantly |
| | | |exposed to smoke. Another well-documented form of indoor air pollution relates to the use of natural gas |
| | | |for cooking. |
| | | |The role of such pollution, however, remains controversial. Thus a part of familial aggregation may be |
| | | |related to home air pollution. |
6.2.6- Plan of treatment-
1st phase treatment – “Watchful waiting”. The placebo along with the conservative treatment to be given till such time that there is improvement in the cough and expectoration. The observation is being done preferably at week’s interval or two week’s interval as required. In case of no improvement, or aggravation the 2nd phase treatment should start. The patient should not be prescribed any medicine till improvement last.
2nd phase Treatment – The indicated medicine along with the general management, to be followed up at a periodic check-up to assess the progress in the case.
|7. PROCEDURES AND METHODS |
|7.1. Enrollment |
|The enrollment procedure after presentation to a specific site is as follows: |
|Four stages for Participant selection |
|Stage 1: |Preliminary verbal screening by the OPD doctor for presence of inclusion criteria (FORM A) |
| |Patients will be recruited from those coming to out patients’ department in the institutes where the study has been |
| |assigned. While each site will evolve its own advocacy procedures for attracting research subjects (advertisements, media,|
| |camps, handouts, etc.), they will all follow the standard recruitment procedure. The procedure involves a two stage |
| |screening prior to initiation of the consent procedure. The first screening is a verbal screening by the attending |
| |physician in the OPD. |
| |The OPD doctor will verbally screen the patients presenting with symptoms related to respiratory system between 20-50 |
| |years of age by asking the following questions: |
| |How old are you? |
| |Have you been suffering from productive cough for more than three months? |
| |Is there copious expectoration? |
| |Details will be kept on the number of patients screened by the OPD doctors. It is expected that the site investigators |
| |will ask the OPD doctor to screen as many patients as possible. Subjects who are of relevant age and have both, the |
| |productive cough for more than three months and the copious expectoration, will be sent to the investigating officer for |
| |detailed and recorded screening. |
|Stage 2: |Detailed screening by the investigating officer for presence of inclusion criteria and absence of all exclusion criteria. |
| |The second screening is a standardized-recorded screening by the project medical officer/investigating officer ‘FORM’ A |
| |The investigating officer will examine the patient for the presence of inclusion criteria and exclusion criteria. Those |
| |who are potentially eligible for the study (inclusion criteria present and all exclusion criteria absent) will then be |
| |subjected to a Baseline assessment by the investigating officer to re-confirm presence of inclusion criteria and absence |
| |of all exclusion criteria. |
| |Details will be kept on the number of patients screened by the investigator. |
| |For a site to stay in the study a minimum of 8 subjects must be enrolled in any month period and follow-up must be more |
| |than 95%. In addition, the site must follow the clinical parts of the protocol stringently. To complete the study within|
| |the stipulated time frame, each site is required to make all efforts to enroll at least 8 cases per month into the study.|
| |This would give a sample size of about 200. Care must be taken to recruit cases in all twelve months of a year to |
| |represent all seasons. |
|Stage 3: |Informed written consent of potentially eligible subjects |
| |The purpose of the study will be explained to patients and oral informed consent to participate obtained. The patients |
| |eligible to enter the study will be fully informed about the study. The content of the explanation provided to the |
| |patients is described in the attached consent form ( Form B1).The site investigator from all the institutions involved in |
| |the study will obtain the freely given, written consent of the patients to participate in the study. The written consent |
| |form is attached (Form B2). If the patient is not literate, a thumbprint may be substituted for signature, duly witnessed|
| |by somebody in addition to the person requesting consent. |
|Stage 4: |Baseline assessment by the Programme officer shall include a detailed Case record and to re-confirming the presence of |
| |inclusion criteria and absence of all exclusion criteria after carrying out prescribed investigations. |
| | The baseline assessment, using Form C2, will be performed immediately after presentation to the site within 3 days |
| |after presentation to the site, FORM C1 includes: |
| |re-evaluation to ensure that no signs of severe chronic bronchitis or very severe disease are present and |
| |a detailed case history for deciding a patient-specific remedy out of the disease specific medicines indicated in the |
| |case. |
| |Data collected at baseline include: |
| |Name, age, address, detailed description of location and other contact information. |
| |History of present illness (duration of symptoms, etc.) |
| |Medical history to exclude presence of known or suspected |
| |emphysema, cor pulmonale, bronchial asthma, Bronchiectasis, Active pulmonary tuberculosis (open), Cystic fibrosis, |
| |Bronchopulmonary mycosis, Central airflow obstruction, acute bronchitis, pneumonia, pulmonary thrombo-embolism, left |
| |ventricular failure, pulmonary hypertension, chronic respiratory failure, spontaneous pneumothorax, Bronchogenic |
| |carcinoma. |
| |Chronic bronchitis, NOS(J42) and obstructive(J44) as per ICD 10 |
| |Subjects suffering from Persons requiring oxygen therapy and hospitalization; |
| |Cough due to some other underlying disease. |
| |Subjects currently on any other treatment (Homoeopathy or other systems) |
| |Subjects who have discontinued treatment less than two weeks before, |
| |Past history |
| |Family history |
| |Personal history |
| |General and systemic examination |
| |Investigations |
| |Diagnosis |
| |Rubric selection |
| |Repertorisation |
| |Selection of medicine for the Trial. |
| |General management. |
| |The history should include quantification of the degree of cough, expectoration and exertional dyspnoea during |
| |activities of daily living and typical activities for the patient. The physical examination should incorporate an |
| |assessment of the degree of distress of the patient. |
| |Patients who are no longer eligible for the study at the completion of baseline evaluation (e.g. because signs of severe|
| |chronic bronchitis or very severe disease have appeared) will be discontinued from the study and receive usual care as |
| |clinically indicated. All the data will be recorded. |
| |The study personnel will explain and demonstrate to the patient how to take the medicine at home at recruitment and at |
| |all subsequent follow-up visits. |
| |
|Enrolled into study—Yes/No |
|Enrollment of consenter and registration. |
|7.2 SELECT THE RUBRICS TO BE TAKEN FOR REPERTORISATION: |
|Tick the rubric(s) found in the case |No. |( |
|Chest; inflammation; Bronchial tubes |1 | |
|Cough; chronic |2 | |
|Expectoration; copious; chronically |3 | |
|Cough, winter |4 | |
|Expectoration; constant, almost day and evening |5 | |
|Expectoration; copious; paroxysmal cough, after |6 | |
|Expectoration; frequent |7 | |
|Respiration; difficult; cough; with |8 | |
|Expectoration; mucous |9 | |
|Expectoration; mucous; translucent |10 | |
|Expectoration; frothy, |11 | |
|Expectoration; easy |12 | |
|Expectoration; transparent |13 | |
|Expectoration, white |14 | |
|Expectoration; purulent |15 | |
|Expectoration; difficult |16 | |
|Expectoration; yellow |17 | |
|Expectoration; thick |18 | |
|Expectoration; lumpy |19 | |
|Expectoration; balls, in shape of |20 | |
|Respiration; difficult; exertion, after |21 | |
|7.3 Highlight the row(s) below corresponding to the rubric no(s). ticked above: |
|01 |
|Medicine: | | | | |
|Value: | | | | |
|7.5 Basis of prescription |
|Prescription: ____________ |Potency: 30. Dose: single |
|Highlight the disease symptom(s) of the case |No. |State the characteristic symptoms |
|Chest; inflammation; Bronchial tubes |1 | |
|Cough; chronic |2 | |
|Expectoration; copious; chronically |3 | |
|Cough, winter |4 | |
|Expectoration; constant, almost day and evening |5 | |
|Expectoration; copious; paroxysmal cough, after |6 | |
|Expectoration; frequent |7 | |
|Respiration; difficult; cough; with |8 | |
|Expectoration; mucous |9 | |
|Expectoration; mucous; translucent |10 | |
|Expectoration; frothy |11 | |
|Expectoration; easy |12 | |
|Expectoration; transparent |13 | |
|Expectoration, white |14 | |
|Expectoration; purulent |15 | |
|Expectoration; difficult |16 | |
|Expectoration; yellow |17 | |
|Expectoration; thick |18 | |
|Expectoration; lumpy |19 | |
|Expectoration; balls, in shape of |20 | |
|Respiration; difficult; exertion, after |21 | |
|7.6 Assessment |
|7.6.1 (periodical – two-weekly) |
|The “zero” will be the time of enrollment. The study personnel will call the patient every two weeks or earlier, if need be, for the |
|follow-up visit and will examine the patient. The investigator will review the key variables. Those patients who smoke will be advised to|
|quit smoking. |
|All the patients will be taught to recognize the signs of worsening illness according to those outlined in Baseline assessment form. They|
|will be advised to report to the Institute if any of the signs develop at any time before the scheduled visit. The following observation |
|will be made and recorded in case report forms: |
|Presence or absence of productive cough. |
|Change in expectoration. |
|Status of exertional dyspnoea |
|Presence or absence of added sounds in chest. |
|Presence or absence of fever. |
|Any ill contacts; any associated symptoms such as nausea, vomiting, diarrhea, myalgias, and chills. |
|Signs of severe chronic bronchitis. |
|Signs of very severe disease. |
|Number of doses of medicines taken. |
|If the patient does not report on a date (fixed) contact shall be made in any way. |
|The investigator should attempt to establish the severity of exacerbation as well as the severity of pre-existing disease condition. |
|The more severe, either of these two components, the more likely, that the patient will require hospital admission. |
|7.6.2 Outcome assessment |
|On each follow-up visit an assessment of clinical success or failure shall be made depending upon an overall response to treatment and |
|the same shall be recorded in a master assessment chart. |
|7.6.3 Final Assessment |
|Assessment of cure will be done either after all the potencies (30, 200 and 1M) of the trial drug have been used or after a lapse of a |
|term of 6 months from enrollment of the patient whichever be earlier. Patients who are clinically cured will be discontinued from therapy|
|and put on periodic observation for a symptom-free period up to two years. Those who are not improved will be given a changed therapy |
|after a wash-out period of two weeks, following the same guidelines as for the selection of the first prescription and this case shall be|
|taken as a new drug trial case in the study. |
|Degree of improvement- |
|1. Marked ( more than 75% improvement in Symptom score from Base line score) |
|Moderate ( 50% to less than 75% improvement in Symptom score from Base line score) |
|Mild ( 25% to less than 50% improvement in Symptom score from Base line score) |
|Not Significant ( less than 25% improvement in Symptom score from Base line score) |
| |
|II Worsened ( Increase of Symptom score from Baseline) |
|III Static ( No change of Symptom score from Baseline) |
|Treatment schedule (time-line) - -(clinical study on chronic Bronchitis) |
| |
|Sl. No. |
|Time |
|Event |
|Form to be filled |
| |
|1 |
|Day 1 |
|Screening |
| |
|FORM A |
| |
|2 |
|Day 2-5 |
|Baseline assessment and inclusion into study, consent, case recording and repertorisation |
| |
|FORMS B1, B2, C1, C2 , Repertorisation Sheet |
| |
|3 |
|Day 6-8 |
|Homoeopathic therapy initiated |
| |
|Ref. 4.5.2 |
| |
|4 |
|1 month to 3rd month |
|Monthly follow-up with photographs |
|FORM D |
| |
|5 |
|On completion of 3 months |
|Detailed assessment in comparison with baseline assessment and photographs |
| |
|FORM E |
| |
|6 |
|On completion of 1 year |
|Repeat assessment, plus photographs and continuation of therapy, if required |
|FORM H |
| |
|7 |
|1 year to 2 year |
|Monthly follow-up as required and continuation of therapy, if required |
|FORMS D, E1, F1 & G1 |
| |
|8 |
|On completion of 2 |
|Repeat assessment, plus photographs |
|FORM H1 |
| |
|9 |
|2 year to 3 year |
|Monthly follow-up as required and continuation of therapy, if required |
|FORMS D, E2, F2 & G2 |
| |
|10 |
|On completion of 3 years |
|To prepare the Summary report of each case studied, so far, under this clinical study |
| |
|FORM H2 |
| |
|11 |
|After completion of 3 years+ 2 months |
|Concluding Report |
|FORM I |
| |
| |
|8 CRITERIA FOR WITHDRAWAL OF PATIENTS |
|when and how to withdraw the subject |
|It is the responsibility of the site investigator to maintain the patient in the study, provided it is safe to do so. A patient may be |
|discontinued from the study for any of the following reasons, that must be documented on the appropriate case report form: |
|8.1.1. Clinical failure after complete treatment |
|No change in Symptomatology of the subject |
|Aggravation of complaints of the patient |
|occurrence of a serious adverse event |
|No improvement in symptom score from baseline assessment score |
|Serious Intercurrent illness |
|No adverse events are expected during homoeopathic therapy. But adverse events may occur as the natural course of the disease. |
|8.1.3. Patient withdraws consent |
|8.1.4. Protocol is not followed |
|8.2 Data collection and Clinical care of withdrawal patients |
|8.2.1 Such patients will receive medical treatment as directed by their physician. |
|8.2.2 Procedures at discontinuation of enrollment |
|The site investigator is responsible for completion of all appropriate case report forms up to the time that the patient is discontinued |
|from the study. |
|9 RECORD HANDLING |
|confidentiality |
| |
|Patient initials ---- |
|research case no--- |
|Project.-----------------/yr date|
|of enrollment----- |
|Date of initiation of treatment---------- date of completion of |
|treatment---- |
|Followup visits----. |
| |
|month |
|1st month |
|2nd month |
|3rd month |
|4th month |
|5th month |
|6th month |
|7th month |
|8th month |
|9th month |
|10th month |
|11th month |
|12th month |
| |
|date |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
|remarks |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
|all the evaluation forms, reports and other records will be kept in locked file cabinet. The patient shall be issued an identity card as follows: |
|Patient identity card for follow up |
|RECORD KEEPING |
|There are 10 study forms that will be completed by all the sites for each subject recruited. There are 2 Consent forms for obtaining the informed |
|written consent of the enrolled case. There are 3 reporting proformas, which are to be sent to HQ, at specified time. |
| 9.3 Dissemination, notifications & reporting – |
|9.3.1 All data derived from the multicentric study will be the property of the Council. |
| |
|9.3.2 The principle papers on the primary and secondary out comes emerging from the multicentric study will be published under joint |
|authorship (task force study). The names of the scientists who have participated in the proposal development and data analysis will be |
|listed at the end of the paper in alphabetical order and their specific contribution to the study will be mentioned. |
| |
|9.3.2 Sites participating in the multi centric study will then be listed in alphabetical order. Authorship issue for site investigators |
|will rest with the Director of the Council. Each site team will be encouraged to produce scientific manuscripts and technical reports |
|based on their site-specific data. Scientists will be encouraged to present the findings at scientific conference and meetings with the |
|prior approval of the Director, CCRH. |
| |
| |
| 9.4 Study management at site: |
|Each site will be responsible for setting up an information system to keep track of all patients screened and enrolled and a filling |
|system to keep all study records – case history records, study protocol and or related documentation and drug distribution records. The |
|site investigator is responsible for the completeness and accuracy of the study materials |
| 9.5 Case History records: |
|These include the study case report forms (CRFs) that will contain information that documents the subject’s ability to participate in the|
|study (including a copy of a signed consent form) and information from tests and examinations. Whenever possible copies of supporting |
|documentation of the information contained in the study case report forms should be kept with each patient’s case history records. All |
|information in the case history records should be attributable to a specific individual. Each subject’s case history record will be |
|evaluated to verify the validity and completeness of the data on the CRF when a study monitor visits the study site. |
|Each CRF should be complete with follow up sheets and are to be maintained properly. All corrections to the CRFs must be made without |
|obscuring the original entry. The revised entry should be inserted and the person making the correction should sign and date the |
|correction. Only authorized study personnel may complete or correct case report forms |
| 9.6 Records retention: |
|Retention of accurate and complete records is essential to establish the validity and completeness of the study. All records must be |
|retained for 5 years after the data set is frozen |
10. MONITORING AND INSPECTION
| 10.1 Project Monitoring and reviews : |
|Site visits: Site visits will be made by the monitoring officer at CCRH Hqrs. between 3-6 months after commencement of studies. |
|Presentation of interim data by the site investigator will be made at Hqrs. |
|Data review board will monitor the information with respect to deviations from the study protocol, in- appropriate enrollment of study |
|subject, missed observations etc. and will suggest plan to rectify any problems at the site. |
| 10.2 Interim assessment of the study |
|On the basis of interim report received from the different centers involved in the clinical study, assessment will be made regarding |
|progress of the clinical study, Interim analysis will be placed before the data review board for suggestions in improvement or |
|modifications, if required in the protocol. DRB will also assess for compliance of protocol by the study site. Non compliance may |
|result into closure of study at particular site. |
|10.3 Quality control: |
| Once the project has been cleared by the Scientific Advisory Committee and Ethical Committee, a |
|centralized workshop will be organized for research officers (to be involved in specific study) to ensure |
|standardization and quality control. An external reviewer will visit all the sites after the initiation of the study for |
|quality assurance. A random subset of records from each site will be evaluated for quality control. Investigators |
|will be asked to bring all medical records ( and results of laboratory tests etc.) for selected subjects to data |
|analysis workshop. Information in the medical records will be compared with the data on the case report form to |
|assess completeness and accuracy of reported data. |
| 11 DATA ANALYSIS AND MANAGEMENT: |
|11.1 Reporting Guidelines |
|All centres will send monthly report as per reporting proforma 1 on case recruitment to headquarters either by fax or |
|e-mail on 1st to 7th of each month. |
|An interim assessment report as per reporting proforma 1I of all the cases enrolled is to be submitted on completion of |
|3rd month of the study of the study. |
|3. An interim assessment report as per reporting proforma 1II of all the cases enrolled is to be submitted on completion|
|of 6th month, 9th month, 1st yr, 2nd yr,3rd yr of the study of the study. |
|Data review board will assess the research data as reported in 6 months assessment form as well as first and second |
|interim report. |
|4. Final assessment report on completion of the study (after 3 years) is to be submitted to hqrs as per reporting |
|proforma IV. |
|11.2 Data analysis plan : |
|Co-ordinating cell at CCRH hqrs. will finally compile and analyze data received from all the centres in consultation with |
|Data Review Board. |
|11.3 Institutional Data Review Board |
|Institutional Data Review Board (IDRB) shall make Interim review of the data of the study every six months. |
|12 TRAINING |
|A training module will be prepared detailing out various modes of training to be imparted to the concerned staff at each |
|of the centers of trial. |
|13 ETHICAL REVIEW |
|Although homoeopathic medicines, proposed to be used during the study, are homoeopathic pharmacopoeal preparations (no new|
|drug is proposed to be tried)Necessary Clearance of the Ethical Committee has been obtained before under taking the study|
| 14 LIMITATIONS OF STUDY: |
|Non achievement of sample size at a particular site/centre – |
| |
|In case of non achievement of sample size in the study period, there will be option for extension of the study for a|
|further limited period after due approval of Scientific Advisory Committee of the Council. |
|If a particular site/centre fails to achieve the sample size in first 6 months, or not complying to the protocol, |
|the study will be discontinued and there will be an option for inclusion of one more centre after due approval of |
|Scientific Advisory Committee. |
| |
|2. Since only a group of medicines have been selected for trial to minimize variables, it may be possible that in |
|some cases, medicines out of these trial medicines may be indicated as per symptom similarity. Those cases are to be|
|treated according to general treatment guidelines of Homoeopathy and are not to be included in the study. |
|15. Time line |
|1. |Draft protocol, submit to EC and IDRB and Constitution and 1st meeting of the Data |oct 2005 |
| |Monitoring committee | |
|2. |Pre-trial preparations: |November 2005 |
| |Organise purchase of drugs, equipment, furniture, etc., printing of programmes for | |
| |data entry and management | |
|3. |Quality assurance workshops |November 2005 |
| |(For standardized training of appointed investigators at all centres in outcomes | |
| |assessment, data collection, reporting, etc.) | |
|4. |Recruitment in main study |november 2005 onwards till the specified |
| | |sample size is achieved, or two years, |
| | |whichever be earlier. |
|6. |Quality assurance site visits: |Quarterly |
|7. |Interim analysis |April 2006, -07, -08 and 2009 |
|8. |Subsequent meetings of *Data Monitoring Committee |October 2006, 2007, 2008 and 2009 |
|9. |Data compilation and analysis |December 2009 |
*The Data Monitoring Committee can meet at any time on the call of the Chairperson
16. CASE DEFINITIONS
|16.1 Chronic bronchitis |
|A condition associated with excessive tracheobronchial mucus production sufficient to cause cough with expectoration for at least 3 |
|months of the year for more than 2 consecutive years. |
|The patient with chronic bronchitis with obstruction has a long history of cough and sputum production with a later onset of wheezing, |
|whereas the asthma patient with chronic obstruction gives a long history of wheezing with later onset of chronic productive cough. |
|The patient with predominant bronchitis usually has an impressive history of cough and sputum production for many years with an immodest |
|history of cigarette smoking. Initially the cough is present only in winter months, and the patient is apt to seek medical attention, if |
|at all, only during the more severe of the frequent mucopurulent relapses. Over the years the cough progresses from hibernal to perennial|
|and mucopurulent relapses increase in frequency, duration and severity. After beginning to experience exertional dyspnoea, the patient |
|often seeks medical help and will be found to have a severe degree of obstruction. |
|The patient with predominant bronchitis is often overweight and cyanotic. There is apparently no apparent distress at rest, the |
|respiratory rate is normal or only slightly increased, and there is no apparent usage of accessory muscles. |
|Chest percussion note is normally resonant, and by auscultation one can usually hear coarse ronchi and wheezes that change in location |
|and intensity after a deep and productive cough. |
|16.2Simple Chronic bronchitis |
|Chronic bronchitis characterized by mucoid sputum production |
|16.3Chronic mucopurulent bronchitis |
|Chronic bronchitis with persistent or recurrent purulence of sputum in the absence of localized suppurative diseases such as |
|bronchiectasis. |
|16.4 Chronic obstructive pulmonary disease (COPD) |
|Defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), as a disease state, characterized by airflow limitation |
|that is not fully reversible. COPD includes |
|Emphysema, an anatomically defined condition characterized by destruction and enlargement of the lung alveoli; |
|Chronic bronchitis, a clinically defined condition with chronic cough and phlegm; and |
|Small airways disease, a condition in which small bronchioles are narrowed. |
|COPD is present only if chronic airflow obstruction occurs; chronic bronchitis without chronic airflow obstruction is not included within|
|COPD. |
|16.5. Coarse ronchi and wheezes |
|Added sounds are abnormal sounds that arise in the lung itself or in the pleura. The added sounds most commonly arising in the lung are |
|best referred to as wheezes and crackles. Older terms such as rales to describe coarse crackles, crepitations to describe fine |
|crackles,and rhonchi to describe wheezes are poorly defined, have led to confusion, and are best avoided. |
|Wheezes are musical sounds associated with airway narrowing. Widespread polyphonic wheezes, particularly heard in expiration, are the |
|commonest and are characteristic of diffuse airflow obstruction, especially in asthma and chronic obstructive pulmonary disease. These |
|wheezes are probably related to dynamic compression of the bronchi, which is accentuated in expiration when airway narrowing is present. |
|A fixed monophonic wheeze can be generated by localized narrowing of a single bronchus, as may occur in the presence of a tumour or |
|foreign body. It may be inspiratory or expiratory or both and may change its intensity in different positions. |
|Crackles are short, explosive sounds often described as bubbling or clicking noises. When the large airways are full of sputum, a coarse |
|rattling sound may be heard even without the stethoscope. However, crackles are not usually produced by moistness in the lungs. It is |
|more likely that they are produced by sudden changes in gas pressure related to the sudden opening of previously closed small airways. |
|Crackles at the beginning of inspiration are common in patients with chronic obstructive pulmonary disease. Localized loud and coarse |
|crackles may indicate an area of bronchiectasis. Crackles are also heard in pulmonary oedema. In diffuse interstitial fibrosis, crackles |
|are characteristically fine in character and late inspiratory in timing. (7) |
|16.6. Exertional dyspnoea |
|The development of exertional dyspnoea, often described as increased effort to breathe, heaviness, air hunger, or gasping, can be |
|insidious. It is best elicited by careful history focused on typical physical activities and how the patient’s ability to perform them |
|has changed. Activities involving significant arm work, particularly at or above shoulder level, are particularly difficult for patients |
|with COPD. Conversely, activities that allow the patient to brace the arms and use accessory muscles of respiration are better tolerated.|
|Examples of such activities include pushing a shopping cart, walking on a treadmill, or pushing a wheelchair. As COPD advances, the |
|principal feature is worsening dyspnoea on exertion with increasing intrusion on the ability to perform vocational or avocational |
|activities. In the most advanced stages, patients are breathless doing simple activities of daily living. |
|16.7 The physical examination |
|It should incorporate an assessment of the degree of distress of the patient. Specific attention should be focused on tachycardia, |
|tachypnea, use of accessory muscles, signs of perioral or peripheral cyanosis, the ability to speak in complete sentences and the |
|patient’s mental status. The chest examination should establish the presence or absence of focal findings, degree of air movement, |
|presence or absence of wheezing ,asymmetry in the chest examination (suggesting large airway obstruction or pneumothorax mimicking an |
|exacerbation) and the presence or absence of paradoxical motion of abdominal wall. |
|16.8 Alterations in Ventilatory Function(2) |
| |TLC |RV |VC |FEV1/FVC |MIP |MEP |
|Obstructive |N to ( |( |( |(a |N |N |
|Restrictive |
|Pulmonary parenchymal |( |( |( |N to ( |N |N |
|Extraparenchymal - inspiratory |( |N to ( |( |N |(/Nb |N |
|Extraparenchymal – inspiratory + expiratory |( |( |( |Variable |(/Nb |(/Nb |
a Mild obstructive (small airways) disease may have decreased FEF25-75% with normal (N) FEV1/FVC
b Reduced if due to respiratory muscle weakness; normal if due to chest wall stiffness.obstructive (small airways) disease may have decreased FEF25-75% with normal (N) FEV1/FVC
TLC = Total Lung Capacity RV = Residual Volume VC = Vital Capacity
FEV = Forced Expiratory Volume FVC = Forced Vital Capacity MIP = Maximum Inspiratory Pressure
MEP = Maximum Expiratory Pressure FEF = Forced Expiratory Flow
17 BIBLIOGRAPHY
Eugene Braunwald, et al. Harrison’s Principals of Internal Medicine, Volume II, McGraw-Hill, Medical Publishing Division, 15th Edition 2001; 258:1451-1459..
Kasper Dennis L., et al. Harrison’s Principals of Internal Medicine, Volume II, McGraw-Hill, Medical Publishing Division, 16th Edition 2005; 242:1547-1554.
1. Tierney, Lawrence M., et al. CURRENT Medical Diagnosis & Treatment, Lange Medical Books/McGraw Hill, Medical Publishing Division, 44th Edition 2005; 9: 235-240.
2. W.H.O., ICD-10, International Statistical Classification of Diseases and Related Health Problems, Volume 1, World Health Organization, Geneva, Tenth Revision 1992; J40-J47:533-537.
3. Haslett, Christopher, et al. Davidson’s Principles and Practice of MEDICINE, Churchill Livingstone, 19th Edition 2002; 13:508-512, 516.
4. Swash Michael. HUTCHISON’S CLINICAL METHODS, W.B. SAUNDERS, 21st Edition 2002; 5:67.
5. Zendvoort, Roger Van. Complete Repertory, Mac Repertory for Windows, Kent Homoepathic Associates, USA.
6. Dubey, S.K. Textbook of Materia Medica. Calcutta, Hahnemann Publishing house
7. Hahnemann, Samuel. Organon of Medicine. 6th edition. New Delhi, B. Jain Publishers.
18 ATTACHMENTS
18.1 FORMS (relating to cases registered for clinical study)
|Sl.no. |FORM |Name |Period |Page no. | |
|1 |FORM A |Detailed screening form|At the time of registration in OPD|66 |To be filled for each case reported in |
| | | | | |OPD for the treatment of tropical |
| | | | | |eosinophilia |
|2 |Form B1 |Patient’s information | |67 |once |
| | |sheet | | | |
|3 |FormB2 |Written consent form |In case of absence of exclusion |68 |To be filled once in each case, |
| | | |criteria | |registered for assigned clinical study |
|4 |FormC1 |Case taking proforma |To be taken for eligible subjects |69 |To be filled once in each case, |
| | | | | |registered for assigned clinical study |
|5 |FormC2 |Baseline assessment |-do- |77 |To be filled once in each case, |
| | |form | | |registered for assigned clinical study |
|6 |FormD |Follow up |monthly |80 |Minimum12(mainly depends on no. of visits|
| | |(assessment)-every | | |of patient during the course of study) |
| | |visit | | | |
|7 |FormE-G |Assessment –3rd, 6th, |3rd month/6th month/9th month/15th|82 |Maximum 01(mainly depends on no. of |
| | |9th months |month/18th month27th month/21st | |visits of patient during the course of |
| | | |month/30th month/33rd month | |study) |
|8 |FormH |Assessment –on |1st year/2nd year/3rd year |89 |Maximum 01(mainly depends on no. of |
| | |completion of 1 year | | |visits of patient during the course of |
| | | | | |study) |
18.2 Study periodical reporting proformae(to be submitted during the course of study)
| | | | | | |
|Sl.no. |Study proforma |Name |Number |Page no. | |
|1 |study reporting proforma I |Monthly reporting proforma |12x3 years=36 |91 |Contains information related to |
| | | | | |the month reported for |
|2 |study reporting proforma II |Interim report(after 3 |1x3years=3 |92 |Contains information related to |
| | |month) | | |three months(April- June) of |
| | | | | |the year reported for |
|3 |study reporting proforma III|Interim report(after 6th |1x3years=3 in each |96 |Contains information related to |
| | |month/9th month/1st yr/2nd |specified period | |6/9/12 months(April to Sept:6 |
| | |yr/3rd yr | | |months/April to December:9 |
| | | | | |months/April to March of the |
| | | | | |subsequent year:1 year) of the |
| | | | | |period reported for |
|4 |study reporting proforma IV |Consolidated report |1 |100 |Contains detailed information |
| | | | | |related to all events within |
| | | | | |three years(April 2006 |
| | | | | |–March2009) |
3. Others
1. List of Monitoring committee
o Dr. Vikram Singh, Co chief coordinator,
o Dr. Hari Singh,Co chief coordinator,
o Dr. Jaya Gupta,coordinator,
o Programme officer at the unit or Incharge of the unit.
18.3.2 List of institutional data review board
FORMS:
FORM A
Detailed Screening Form
Serial number __________
Site Code ______________________
Date _________________
1. Age _____________
2. Sex: Male/Female
3. Is age >20 and | |
|Extention & spread. Duration & Frequency) | | | |
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B. Associated complaints(in chronological order with duration.) Each
symptom should be completed.
|location & extension |Sensation (includes pathology ) |Modalities |concomitants |
|( includes tissues, organs,systems. | |includes < & > | |
|Extention & spread. Duration & | | | |
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3. HISTORY OF PRESENT ILLNESS ( includes nature of onset, duration, progress, mode of treatment, effect of
treatment, and any relation with cause*)
4. LIFE SPACE INVESTIGATIONS (should take form of a biographical account) Record, if any factor, out of these has relation with present complaints or effect on mind and disposition of the patient: -
4.1 Birth and early development (Mother’s condition during pregnancy; normal or abnormal birth; feeding difficulties, difficulties in habit training and delay in achieving milestones (walking, talking and sphincter control, etc.).
4.2 Behaviour during childhood (Play and favourite toys; any periods of separation from parents and the patient’s reaction to them; temper tantrums; hyperactivity; frequent fights; violence; model child. Bed-wetting or soiling; eating problems; stammering; recurrent physical complaints, e.g. abdominal pain).
3. Schooling (Age of starting and finishing school; type of school; academic achievements; special abilities or disabilities; relationship to peers and teachers; school refusal; school truancy; ambitions. Obtain information for both primary and secondary schooling).
4. Adolescence & Psychosexual history (Introduction to facts of life; early sexual experiences; parental attitude towards sex; sexual abuse in childhood. Masturbation and sexual fantasies; homosexual and heterosexual experiences apart from marriage; emotional relationship to partners; sexual difficulties; sexual deviation; current sexual activities. Attitudes to parents, authority figures and peers; reaction to growing up, puberty and bodily changes; fantasy life; attitude to sexuality including masturbation and any early homosexual and heterosexual experiences; drug taking; rebelliousness and delinquency. New interests).
5. Occupational history (Age of starting work; jobs held in chronological order and reasons for change; satisfaction from work; work ability and ambitions; relationship to work mates, superiors and subordinates. Leisure activities).
_____________________________________________________________________________________________________
*- precipitating/ exciting/ never well since/ ailments from
6. Marital history (Previous engagements and marriages; reasons for marriage; husband’s or wife’s age, occupation, health and personality; marital relationship – satisfactions, dissatisfactions, any sexual difficulties; extra-marital relationships and sexual fantasy life).
7. Children (Chronological list of children with ages, first names and health. Miscarriages, stillbirths or death of a child. Patient’s reactions to these events and attitude to existing children).
8. Present social history (housing, composition of household, financial problems, emotional atmosphere of home and its effect on patient, diet and daily routine etc.)
9. Alcohol and drug history (Details of smoking and drinking habits; any recent change or adverse effect on physical health or social activity, e.g. occupation, family relationships and financial situation. Use of other drugs, e.g. heroin, LSD, cocaine, amphetamines, barbiturates, cannabis, tranquillizers. How are they obtained – prescription, black market? How are they financed?
10. Travel history
11. Personality before illness (Pre-morbid personality)- include relationships, leisure activities (hobbies and interests, membership of societies and clubs), predominant mood (anxious, worrying, cheerful, despondent, optimistic, pessimistic, self depreciating, over confident; stable or fluctuating; controlled or demonstrative), character (sensitive, reserved, timid, shy, suspicious, jealous, resentful, quarrelsome, irritable, impulsive, selfish, self centered, self conscious, lacking in confidence, dependent, strict, fussy, rigid, meticulous, punctual, excessively tidy), attitudes and standards (moral and religious, attitude towards health and the body), habits (food, alcohol, tobacco, drugs)
4.12. Life chart of the patient:
|Date |Age | Events | Expression | Cause | Inference |
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4. PAST MEDICAL HISTORY (Illnesses, operations and accidents in chronological order; treatment received – when and by whom. The patient’s reactions to them).
|S. |Approx. Age/Year |**Past Illness (including duration of illness) |Treatment |
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| | | |Adopted |Response |
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|**- Includes diagnosed illnesses (if records available) / otherwise presenting complaints & nature of illness. |
5. FAMILY HISTORY (in case of adoption or fostering, details should be taken of both the real family, if possible,
and the adoptive or foster family):
|Relation |Alive |Dead |Cause of death |Illnesses suffered |
| |(age) |(with age) | |/suffering from |
|Father | | | | |
|Mother | | | | |
|Brother | | | | |
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|Grandfather (P) | | | | |
|Grandmother (P) | | | | |
|Grandfather (M) | | | | |
|Grandmother (M) | | | | |
|Uncle (P) | | | | |
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|Aunt (P) | | | | |
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|Uncle (M) | | | | |
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|Aunt (M) | | | | |
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|Husband /Wife | | | | |
7. MENSTRUAL HISTORY (if applicable):
Menarche:
Complaints related to Menarche, if any:
L.M.P.:
|Regular/ |Character of Flow |COMPLAINTS |
|irregular Cycle/| | |
|Duration | | |
| |Quantity |Consistency & clots |Colour & Stains |
|Quantity & |Colour & | Odour |Acridity | | | |
|consistency |Stains | | | | | |
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8. OBSTETRIC HISTORY (if applicable): Data of childbirths, including miscarriages and therapeutic abortions, and complaints related with pregnancies, labor, puerperium and lactation.
1 Previous pregnancies including abortion:
G (gravida) P (para) A (abortion) S (still birth) L (Living)
|No. |Period of |Complaints |Date & |Nature of |Child |Lactation |
| |pregnancy |in pregnancy/ |nature of |puerperium | |history |
| | |treatment |labor* | | | |
| | |adopted | | | | |
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|Taste | |
|Thirst | |
|Desire / Cravings | |
|Aversion/ Repugnance | |
|Food Aggravation/ Intolerance | |
|Food Amelioration | |
|Stool | |
|1 |Physical properties | |
|2 |frequency | |
|3 |urging | |
|4 |satisfaction | |
|5 |Modifying factors | |
|6 |concomitants | |
|7 |any other | |
|Urine | |
|1 |Physical properties | |
|2 |Frequency (day/night) | |
|3 |urging | |
|4 |difficulty | |
|5 |control | |
|6 |pain | |
|7 |Any other | |
|Sweat | |
|1 |Physical properties | |
|2 |location | |
|3 |staining | |
|4 |in relation to weather | |
|5 |Any other | |
|Discharges | |
|1 |Abnormal secretions | |
|2 |Excretions | |
|Urethral discharge (In men) | |
|1 |Physical properties | |
|2 |Modifying factors | |
|3 |Concomitants | |
|Sleep (Pattern, position of body during sleep, sleep related problems, | |
|effect of sleep on health) | |
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|Dreams[ Recurrent Persistent,Vivid ] | |
|Tendencies | |
|1 |Haemorrhagic | |
|2 |Suppurative | |
|3 |Catching cold | |
|4 |Spasms/Cramps/Sprain | |
|5 |Any other | |
|Weakness | |
|Tiredness (Is it loss of energy or boredom, or a part of general | |
|malaise?) | |
|Is there unusual fatiguability? | |
|Lassitude | |
General reaction to:
|Factors |Aversion |Desires |Intolerance/ |Aggravation |Amelioration |
| | | |Sensitive to | | |
|Time | | | | | |
|Thermal/ Season | | | | | |
|Air/fanning | | | | | |
|Clothing | | | | | |
|Bathing/Washing | | | | | |
|Any food items | | | | | |
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|Touch/Pressure | | | | | |
|Posture | | | | | |
|Motion | | | | | |
|Noise | | | | | |
|Light | | | | | |
|Odour | | | | | |
|Any other factor(s) | | | | | |
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9.- PSYCHIC FEATURES* with causative or modifying factors, Aberration of mind, morbid affections of the moral & intellectual.
A. EMOTIONS (anxiety, anger, fears, greed, company, consolation, conversation, spoken to, suicidal tendencies, contradiction, trifles, exertion/ work, pleasure/music, magnetized etc. including
History of emotional upset i.e. anger, bad news, displeasure, repressed / suppressed), disappointment, fright, grief, joy,
shock,sorrow,tension,vexation,worries,etc.)
B. INTELLECT & MEMORY - - {includes Perception (acute/clear/confused/dull, ecstasy, clairvoyance,
visions, hallucination, illusion etc.), Thinking (active/ sluggish, emotional/ logical, fancies/ daydreams, difficult, fixed/ changeable, grandiose/ unreal/ practical, reverie / systematic, delusions/imaginations, confusion, guilt complexes comprehension, etc., if any other, specify. loss-sudden, weak, acute/sharp, difficult, absent-minded, forgets recent event(s) but remembers past events, forgets names/titles/places, etc.)
C WILL including desire/aversion in general(/ special senses ,strong with a drive
D BEHAVIOUR OF PATIENT - Mild & Placable / Boisterous & Violent/ Firm/ Yielding/ Lively & Communicative/ Reserved & Taciturn/ Anxious/ Apprehensive/ Timorous/ Irritable/ Introvert/ Extrovert, etc.
E. ANY OTHER, SPECIFY
10 PHYSICAL EXAMINATION
10.1 GENERAL PHYSICAL EXAMINATION:
Anaemia ……Jaundice…….. Cyanosis………Oedema (general/ partial)…………
Lymph nodes (cervical, axiliary, inguinal, etc.)……………………….
Blood pressure… …../….. mm of Hg ….Pulse rate………/ min. Temperature……°F
Respiratory rate..… / min
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*- especially change in mind & disposition during disease is to be highlighted.
Also mention:
1. Are the intellectual functions, power of thought, memory or desire or ability for mental or bodily exercise weakened?
1. Are mental emotions of long continuance, or are they very transient? Whether patient suffers patiently or is inclined to weep, to be morose, passionate, despairing, greatly anxious or fearful etc. or whether the mind is remarkably affected in these respects by the disease?
2. REGIONAL EXAMINATION*:
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|Body Built |(Obese/ lean/ stocky) |
|Stature |large/ small |
|Weight (Increasing/decreasing/stationary) | Kg. |
|Gait | |
|Posture | |
|Deformities | |
|Complexion |(Fair/ wheatish/ dark/ florid/ pale) |
| |Clean/dirty |
|Look |Premature old/ Childish/ young/ Senile |
|Facial configuration & expression | |
|Scalp / Head | |
|Hair |(colour & condition) |
|Eyes | |
|Pupil | |
|Vision | |
|Ears | |
|Ear wax |Dry/ fluid, fetid/ odorless |
|Hearing | |
|Chin | |
|Jaw | |
|Nose | |
|Mouth | |
|Taste | |
|Lips | |
|Tongue | |
|Gums | |
|Breath (odour) | |
|Teeth | |
|Speech & voice | |
|Pulse | |
|Hand | |
|Palms | |
|Fingers (Clubbing) | |
|Nails | |
|Toes | |
|Thyroid | |
|Perspiration | |
|Location | |
|Physical properties |Acrid, Bloody, Burning, Clammy, Cold, Warm, Diminished, |
| |Excessive, Odors, Oily, Staining, Sticky, Suppressed, absent |
|SKIN | |
|Coldness |General |
| |Partial (location) |
|Heat, Warmth |General |
| |Partial (location) |
|Any growths (Tumuors, Exanthemata, Warts, Corns, | |
|Cysts etc) | |
|Discoloration | |
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*- Give tick ( ( ) mark wherever applicable
3. SYSTEMIC EXAMINATION* [DETAILS MAY BE TAKEN ACCORDING TO RESEARCH
PROTOCOL](Firstly and thoroughly the system under suspicion- Next other systems in turn, considering the important points only). Basically each system is examined by
i. Inspection ii. Palpation iii. Percussion iv. Auscultation v. Special and Instrumental
examination as and when necessary.
| |Detail of system affected |
|Respiratory system- | |
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|Cardiovascular system- | |
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|Nervous system- | |
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|Gastro-intestinal system- | |
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|Genito urinary system- | |
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|Locomotor system | |
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|Joints and bones- | |
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11. LABORATORY INVESTIGATIONS (whichever applicable to the research project)
(Including previous investigations got done by the patient, if any. Positive findings may be recorded in the relevant annexure of assigned problem) (Attach separate sheet)
12. DIAGNOSIS :
13. ANALYSIS AND EVALUATION OF SYMPTOMS:-
|Causation |Mental generals |Physical generals |Uncommon symptoms |Particulars |Common symptoms |
| | |(including side affinity, |(Characteristic, Key Note, | | |
| | |if any) |Peculiar sensations, | | |
| | | |Concomitants, Modalities | | |
| | | |etc.) | | |
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Score
14. BASELINE SYMPTOM SCORE
(Attach Baseline (document)
15. MIASMATIC ANALYSIS:
|Symptoms |Psora |Sycosis |Syphilis |Tubercular |
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Conclusion-Dominant miasm:
16. TOTALITY OF SYMPTOMS:[PQRS* in respect of Mental/ Physical Generals & Particulars; Causation; Past history; Family history & Pathological changes]
17. SELECTION OF MEDICINE: (attach Repertorial sheet, wherever applicable)
17.1. - Repertorization-
|Repertory used: | | |
|Method of Repertorization- | | |
|Chapter |Symptoms Selected |Rubrics |
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*- Peculiar, Queer, Rare symptoms
17.2 Repertorial analysis:
18. FIRST PRESCRIPTION:
1. Justification of the prescription
2. Prescription
Date ………….. Name of medicine and potency ………………………..….
Dosage ………
Number of days……………….
18.3. General Supportive Care:[According to protocol ]
Note: - 1. case taking should be in legible writing
2. No column should be left blank
3. NP- nothing particular
4. NK – not known
signature signature
investigator Incharge of the institute/unit
Form C2
Baseline Assessment
Serial number __________
Site Code ______________________
Date _________________
Name of Patient ______________________________________ Sex: Male/Female Age _______________
Address ____________________________________________________________________________________
_________________________________________ Tel ___________________ e-mail ______________________
1. HAS THE WRITTEN INFORMED CONSENT OF THE PATIENT BEEN TAKEN: Yes / No
If ‘Yes’ then proceed further.
2. HISTORY OF CURRENT ILLNESS (Complete or circle correct response):
• Duration of productive cough : _______ (valid more than 3 months).
• Seasonal: summer/winter/rainy/change. _______ days
|Symptom score at entry level |
|(Symptom/Score( |0 |1 |2 |3 |4 |
|Chronic Cough |Absent | |Present | | |
|Severity | |Mild |Moderate | |Severe |
| | |(irritating) |(distressing) | |(spasmodic) |
|Paroxysms [duration] |nil |1 hr to 6 hrs |6 hrs to 12 hrs |12 hrs to 18 hrs |18 hrs to 24 hrs |
|Expectoration |Absent | |present | | |
|Difficulty in raising | |Easy | |Difficult | |
|Quantity | |Scanty | |Copious | |
| | |Thin | |Thick |Lumpy/ |
| | | | | |in shape of balls |
| | |Mucoid |Frothy | |Purulent |
| | |Transparent/ |White |Yellow |Greenish |
| | |Translucent | | | |
|Difficult respiration |Absent | |Present | | |
| |Absent |Heavy exertion | |Mild exertion |With cough |
|Crackles |Absent | |Present | | |
|Total | | | | | |
|Total of Entry level score: ______________ [10-40] |
|MILD: 10 to 15 MODERATE: 16 to 31 SEVERE:32 -40 |
HISTORY OF ATTACKS IN THE PREVIOUS YEARS
1. Duration of illness in years: ___________
2. Duration of attacks of productive cough : _______ (valid more than 3 months)
3. Seasonal: summer/winter/rainy/change. _______ days
HISTORY OF EXPOSURE TO POLLUTANTS
4. Smoking [ Active/Passive; Duration: ___________; No. of cigarettes per day ___________ ]
5. Environment (Air pollution)/Occupation
6. Respiratory infections
7. Familial factors
|ROUTINE PHYSICAL EXAMINATION (7 ) |
|General | |
|• General appearance (does the patient look | |
|healthy, unwell or ill, well cared for or | |
|neglected?) | |
|• Intelligence and educational level | |
|• Mental state | |
|• Expression and emotional state | |
|• Build and posture | |
|• Skin colour, cyanosis, anaemia, jaundice, | |
|pigmen tation | |
|• Temperature, pulse, respiration rate | |
|Eyes | |
|• Oedema of the lids | |
|• Gonjunctivae: anaemia, jaundice or | |
|inflammation | |
|• Pupils: size, equality, regularity, | |
|reaction to light, accommodation | |
|Mouth | |
|Pharynx | |
|• State of tonsils. | |
|Neck | |
|• Lymphatic glands | |
|Upper limbs | |
|• Fingernails: clubbing or koilonychia | |
|• Pulse: rate, rhythm, volume and character | |
|• Axillae: lymph glands | |
|• Blood pressure | |
|Chest | |
|• Respiration: rate, depth and character | |
|• Position of trachea by palpation | |
|• Palpate respiratory movements | |
|• Estimate tactile vocal fremitus | |
|• Percuss the lungs | |
|• Auscultate the heart sounds | |
|• Auscultate the breath sounds | |
|Posteriorly (patient sitting) | |
|• Inspect and palpate respiratory movement | |
|• Estimate tactile vocal fremitus | |
|• Percuss the lung resonance | |
|• Auscultate the breath sounds | |
|• Estimate vocal resonance | |
|Abdomen | |
|• Hernial orifices | |
|• Palpation: tenderness, rigidity, | |
|hyperaesthesia, splashing, masses, liver, | |
|gallbladder, spleen, kidneys, bladder | |
|• Percussion: masses, liver, spleen, bladder| |
|• Auscultation: bowel sounds, murmurs | |
|Lower limbs | |
|• General examination of legs and feet | |
|• Oedema of feet and ankles | |
|• Varicose veins | |
|• Joints: movement, pain and swelling | |
|Examination of excreta | |
|• Test urine for specific gravity, sugar, | |
|protein and blood. | |
INVESTIGATIONS
|Spirometry: | |Normal values |
|• FEV1 | | |
|• FEV1/FVC | | |
|• TLC | | |
|• Residual Volume | | |
|• Vital Capacity | | |
|X-ray chest: | | |
|Pathological: | | |
|• Hb% | | |
|• TLC | | |
|• DLC | | |
|• ESR | | |
|• Sputum for AFB (3 consecutive days) | | |
|• ELISA for Mycobacterium Tuberculosis | | |
Enrolled into study: Yes / No.
signature Signature Signature
consultant Investigator incharge of the institute/unit
FORM D
Follow up [at every visit]
unique identifier- Site code/screening no./baseline assessment no./research case no./OPD regd no.
Date _________________
Name of Patient ______________________________________ Sex: Male/Female Age _______________
Address ____________________________________________________________________________________
_________________________________________ Tel ___________________ e-mail ______________________
HISTORY OF CURRENT ILLNESS (Complete or circle correct response):
|Symptom score at entry level |
|(Symptom/Score( |0 |1 |2 |3 |4 |
|Chronic Cough |Absent | |Present | | |
|Severity | |Mild |Moderate | |Severe |
| | |(irritating) |(distressing) | |(spasmodic) |
|Paroxysms [duration] |nil |1 hr to 6 hrs |6 hrs to 12 hrs |12 hrs to 18 hrs |18 hrs to 24 hrs |
|Expectoration |Absent |1 hr to 6 hrs |6 hrs to 12 hrs |12 hrs to 18 hrs |18 hrs to 24 hrs |
|Difficulty in raising | |Easy | |Difficult | |
|Quantity | |Scanty | |Copious | |
| | |Thin | |Thick |Lumpy/ |
| | | | | |in shape of balls |
| | |Mucoid |Frothy | |Purulent |
| | |Transparent/ |White |Yellow |Greenish |
| | |Translucent | | | |
|Difficult respiration |Absent | |Present | | |
| |Absent |Heavy exertion | |Mild exertion |With cough |
|Crackles |Absent | |Present | | |
|Total | | | | | |
|Total of Entry level score: ______________ [10-40] |
|MILD: 10 to 15 MODERATE: 16 to 31 SEVERE:32 -40 |
INVESTIGATIONS
|Spirometry: | |Normal values |
|• FEV1 | | |
|• FEV1/FVC | | |
|• TLC | | |
|• Residual Volume | | |
|• Vital Capacity | | |
|X-ray chest: | | |
|Pathological: | | |
|• Hb% | | |
|• TLC | | |
|• DLC | | |
|• ESR | | |
|• Sputum for AFB (3 consecutive days) | | |
|• ELISA for Mycobacterium Tuberculosis | | |
|ROUTINE PHYSICAL EXAMINATION (7 ) |
|General | |
|• Temperature, pulse, respiration rate | |
|Pharynx | |
|• Lymphatic glands | |
|• Pulse: rate, rhythm, volume and character | |
|• Axillae: lymph glands | |
|• Blood pressure | |
|Chest | |
|• Respiration: rate, depth and character | |
|• Position of trachea by palpation | |
|• Palpate respiratory movements | |
|• Estimate tactile vocal fremitus | |
|• Percuss the lungs | |
|• Auscultate the heart sounds | |
|• Auscultate the breath sounds | |
|Posteriorly (patient sitting) | |
|• Inspect and palpate respiratory movement | |
|• Estimate tactile vocal fremitus | |
|• Percuss the lung resonance | |
|• Auscultate the breath sounds | |
|• Estimate vocal resonance | |
MEDICAMENTS, Treatment
Compliance to Homoeopathic treatment
a) Medicines prescribed
b) Continuation of treatment
c) Name of the medicine if changed (Reasons for change)
d) Number of doses taken
Compliance to Instructions
1. Whether medicine taken regularly
2. How many times not taken on scheduled time
3. Any other medicines taken
4. Follow-up of general management (REF 6.2.6)
Other symptoms of the patient as per initial case record:
a) ---------
b) ---------
c) --------- Remarks, if any
signature Signature Signature
consultant Investigator incharge of the institute/unit
FORM E,F,G
Assessment [at 3 months/ 6 months/at 9 months/15th/18th /21st/27th month /30th month/33rd month]
unique identifier- Site code/screening no./baseline assessment no./research case no./OPD regd no.
Date _________________
Name of Patient ______________________________________ Sex: Male/Female Age _______________
Address ____________________________________________________________________________________
_________________________________________ Tel ___________________ e-mail ______________________
|Symptom score at entry level |
|(Symptom/Score( |0 |1 |2 |3 |4 |
|Chronic Cough |Absent | |Present | | |
|Severity | |Mild |Moderate | |Severe |
| | |(irritating) |(distressing) | |(spasmodic) |
|Paroxysms [duration] |nil |1 hr to 6 hrs |6 hrs to 12 hrs |12 hrs to 18 hrs |18 hrs to 24 hrs |
|Expectoration |Absent |1 hr to 6 hrs |6 hrs to 12 hrs |12 hrs to 18 hrs |18 hrs to 24 hrs |
|Difficulty in raising | |Easy | |Difficult | |
|Quantity | |Scanty | |Copious | |
| | |Thin | |Thick |Lumpy/ |
| | | | | |in shape of balls |
| | |Mucoid |Frothy | |Purulent |
| | |Transparent/ |White |Yellow |Greenish |
| | |Translucent | | | |
|Difficult respiration |Absent | |Present | | |
| |Absent |Heavy exertion | |Mild exertion |With cough |
|Crackles |Absent | |Present | | |
|Total | | | | | |
|Total of Entry level score: ______________ [10-40] |
|MILD: 10 to 15 MODERATE: 16 to 31 SEVERE:32 -40 |
INVESTIGATIONS
|Spirometry: | |Normal values |
|• FEV1 | | |
|• FEV1/FVC | | |
|• TLC | | |
|• Residual Volume | | |
|• Vital Capacity | | |
|X-ray chest: | | |
|Pathological: | | |
|• Hb% | | |
|• TLC | | |
|• DLC | | |
|• ESR | | |
|• Sputum for AFB (3 consecutive days) | | |
|• ELISA for Mycobacterium Tuberculosis | | |
MEDICAMENTS, Treatment
Compliance to Homoeopathic treatment
a) Medicines prescribed
b) Continuation of treatment
c) Name of the medicine if changed (Reasons for change)
d) Number of doses taken
Compliance to Instructions
5. Whether medicine taken regularly
6. How many times not taken on scheduled time
7. Any other medicines taken
8. Follow-up of general management (REF 6.2.6)
Other symptoms of the patient as per initial case record:
a) ---------
b) ---------
c) --------- Remarks, if any
Symptom score at Entry level [n0]: _________________
Symptom score after 3 month follow-up [n3]:: __________
Difference in symptom score: ____________ (value in plus or minus)
Overall response to treatment: Better (plus) / No response (zero) / Worse (minus).
Improvement rate: [(n0 - n3) /0.4] % : ____________ (value in plus or minus).
signature Signature Signature
consultant Investigator incharge of the institute/unit
FORM H
Assessment [at 12 months /2yrs/3yrs]
unique identifier- Site code/screening no./baseline assessment no./research case no./OPD regd no.
Date _________________
Name of Patient ______________________________________ Sex: Male/Female Age _______________
Address ____________________________________________________________________________________
_________________________________________ Tel ___________________ e-mail ______________________
|Symptom score at entry level |
|(Symptom/Score( |0 |1 |2 |3 |4 |
|Chronic Cough |Absent | |Present | | |
|Severity | |Mild |Moderate | |Severe |
| | |(irritating) |(distressing) | |(spasmodic) |
|Paroxysms [duration] |nil |1 hr to 6 hrs |6 hrs to 12 hrs |12 hrs to 18 hrs |18 hrs to 24 hrs |
|Expectoration |Absent |1 hr to 6 hrs |6 hrs to 12 hrs |12 hrs to 18 hrs |18 hrs to 24 hrs |
|Difficulty in raising | |Easy | |Difficult | |
|Quantity | |Scanty | |Copious | |
| | |Thin | |Thick |Lumpy/ |
| | | | | |in shape of balls |
| | |Mucoid |Frothy | |Purulent |
| | |Transparent/ |White |Yellow |Greenish |
| | |Translucent | | | |
|Difficult respiration |Absent | |Present | | |
| |Absent |Heavy exertion | |Mild exertion |With cough |
|Crackles |Absent | |Present | | |
|Total | | | | | |
|Total of Entry level score: ______________ [10-40] |
|MILD: 10 to 15 MODERATE: 16 to 31 SEVERE:32 -40 |
INVESTIGATIONS
|Spirometry: | |Normal values |
|• FEV1 | | |
|• FEV1/FVC | | |
|• TLC | | |
|• Residual Volume | | |
|• Vital Capacity | | |
|X-ray chest: | | |
|Pathological: | | |
|• Hb% | | |
|• TLC | | |
|• DLC | | |
|• ESR | | |
|• Sputum for AFB (3 consecutive days) | | |
|• ELISA for Mycobacterium Tuberculosis | | |
MEDICAMENTS, Treatment
Compliance to Homoeopathic treatment
a) Medicines prescribed
b) Continuation of treatment
c) Name of the medicine if changed (Reasons for change)
d) Number of doses taken
Compliance to Instructions
9. Whether medicine taken regularly
10. How many times not taken on scheduled time
11. Any other medicines taken
12. Follow-up of general management (REF 6.2.6)
Other symptoms of the patient as per initial case record:
a) ---------
b) ---------
c) --------- Remarks, if any
Symptom score at Entry level [n0]: _________________
Symptom score after 12 month follow-up [n12]:: __________
Difference in symptom score: ____________ (value in plus or minus)
Overall response to treatment: Better (plus) / No response (zero) / Worse (minus).
Improvement rate: [(n0 – n12) /0.4] % : ____________ (value in plus or minus).
signature Signature Signature
consultant Investigator incharge of the institute/unit
STUDY REPORTING PROFORMA I
MONTHLY REPORTING PROFORMA
.
| |Name of the Institute/Unit | | |
| |Title of Study | | |
| |Name of Reporting Officer | | |
| |No. of cases Attended O.P.D. |T |M |F |
| |New | | | |
| |Old | | | |
| |Total | | | |
| |No. of cases Registered so far since Inception | | | |
| |No. of cases screened | | | |
| |No. of cases given informed consent | | | |
| |No. of cases Investigated for Diagnosis | | | |
| | X-ray | | | |
| | PFT | | | |
| |No. of cases with confirmed diagnosis. | | | |
| |No. of cases found suitable for inclusion into the study. | | | |
| |No. of old cases followed up | | | |
| |a) No. of cases excluded. | | | |
| |b) No. of cases dropped out. | | | |
| |c) No. of cases discontinued from study | | | |
| |d) No. of cases referred | | | |
| |Registration no. of case records enclosed | | |
| | No. of Visits Consultant | |
| |No. of patient seen | T |M |F |
| |New | | | |
| |Old | | | |
|Note- Enclose one copy of one case record of chronic bronchitis registered during the reporting month & follow-up sheet for the case record |
|submitted in the previous monthly report.. |
Follow-up action report in respect of Cases not cleared in
i) Screening, ii) Base line assessment and the cases withdrawn from the study
Project
Total no. of cases loss of follow up
|S.No. |Ref.No. |
| |1.1. |Title of the Study: | |
| |1.2. |Name of the Institute/Unit: | |
| |1.3. |Period of Interim Report: | |
| |1.4. |Primary Objective of the Study: | |
| | |To ascertain therapeutic efficacy of Homoeopathic Medicine(s) in the management of Chronic Bronchitis. |
| |1.5. |Secondary Objective of the Study: | |
| | |To ascertain the role of Homoeopathic medicine and to establish verified characteristic symptoms of medicine used. |
| | |To assess the role of homoeopathic medicines in reversing the pathological changes due to Chronic Bronchitis. |
| | |Determine the most useful strategy for management of the differing intensity. |
| | |To check the progression to complications. |
| | |To prevent the relapse. |
| |1.6 |No. of cases Attended O.P.D. |T |M |F |
| | |New | | | |
| | |Old | | | |
| | |Total | | | |
| |1.7 |No. of cases Registered so far since Inception | | | |
| |1.8. |No. of Cases Studied: |T |M |F |
| | | | | | |
| |1.9. |Staff Engaged in the Project: |
| | | |Name |Qualification |Designation |
| | |i) | | | |
| | |ii) | | | |
| | |iii) | | | |
| | |iv) | | | |
| | |v) | | | |
| | | | | | |
| |1.10. |Number of subject presenting with following symptoms and signs: |
| | |Symptoms/ signs |New |Old |
| | | |T |M |F |T |M |F |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |1.11 |Examination findings: | | | | | | |
| |i) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |ii) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |iii) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |iv) | | | | | | | |
| |v) | | | | | | | |
|1.10- pathological findings – |
| | |New |Old |
|1. |X-ray finding- | | |
|2. |PFT- | | |
|3. |any other finding- | | |
|4. | | | |
|5. | | | |
|2- material– |
|2.1- total no. of research cases |
| | |T |M |F |
|1. |Screened | | | |
|2. |included in study | | | |
|3. |Excluded | | | |
|4. |dropped out | | | |
|5. |loss to follow-up | | | |
|6. |Withdrawn | | | |
|2.2- age distribution |
| | |New |Old |
|1. |40-50 yrs | | |
|2. |50-60 yrs | | |
|3. |60-70 yrs | | |
|4. | | | |
|5. | | | |
|2.3- duration of complaints- |
| | |New |Old |
|1. |range- Minimum ______________ | | |
|2. |Maximum ___________________ | | |
|3. |3 months- to less than 6 months | | |
|4. |6 months to less than 1 yr | | |
|5. |1 yr to less than 5 yr | | |
|6. |6 yr to less than 10 yr | | |
|7 |11 yr to less than 15 yr | | |
|8 |16 yr to less than 20 yr | | |
|9 |20 yrs and above | | |
|2.4- predisposition- |
| | |New |Old |
|1. |smoking | | |
|2. |exposure to allergens | | |
| | | | |
| | | | |
|2.5- clinical types of chronic bronchitis | | |
|1. |simple | | |
|2. |mucopurulent | | |
| | | | |
| | | | |
|2.6- baseline information & post treatment - |
| |symptom score |baseline |post treatment |
|1. |10-15 | | |
|2. |16-31 | | |
|3 |32-40 | | |
|2.7- reduction in baseline symptom score after treatment |
| | |T |M |
|1. |more than 1 and less than 5 | | |
|2. |b/w 5 & 6 less than 8 | | |
|3 |more than 8 & less than 10 | | |
|4 |more than 10 & less than 15 | | |
|2.8- improvement in pathological /examination findings- |
| | |Before Treatment |After Treatment |
|1. |decrease in crackles | | |
|2. |change in X-ray finding | | |
|a |normal | | |
|b |abnormal | | |
|3 |changes in PFT | | |
|3- basis of prescription |
| | |New |Old |
|1. |mental symptoms | | |
|2. |physical characteristics | | |
|3 |repertorial totality | | |
|4 | | | |
|3.1- duration of treatment |
| | |New |Old |
|1. |Minimum | | |
|2. |Maximum | | |
|3 |0-3 months | | |
|4 |3-6months | | |
|5 |6-9 months | | |
|6 |9months to 1 yr | | |
|7 |more than 1 year | | |
|3.2- improvement indices— |
|I degree of improvement- |
| | |New |Old |
|1. |Marked | | |
|2. |Moderate | | |
|3 |Mild | | |
| | | | |
|II |Worsened | | |
|III |Static | | |
|IV |Referred for other treatment- | | |
3.3.1.
|Sl. |Name of Drug with Potency |Indication |No. of cases |NO. OF CASES Improvement |
|No. |& Dosage | |Medicine Prescribed | |
| | | | |Mild |Moderate |Marked |
| | | | | | | |
| | | | | | | |
3.3.2.
|Name of Drug |Clinical symptoms improved |No. of cases |
| | | |
| | | |
| | | |
| | | |
4. Relapse
Relapse with intensity Before and After Treatment
|Intensity Before Treatment |Intensity After Treatment |
| |No of Cases |No of Cases Mild |No of Cases Moderate |No of Cases Severe |
|Mild | | | | |
|Moderate | | | | |
|Severe | | | | |
5. Progression to complications.
|Complications |Name of Medicine(s) with potency |No. of cases |
| | | |
| | | |
| | | |
Number of cases referred for other therapy/ clinical failure
|Baseline Score |Duration of Treatment |Score At Time Of Referral |No.of Medicines Used |Age Of Case |
| | | | | |
| | | | | |
| | | | | |
Number of adverse events
| Name of adverse |Duration of Treatment |Management Done |Name of Medicines Used if |Response to Treatment |
|event | | |homoeopathic Management | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
The most useful strategy for management of the differing intensity
6. 6.1. Problems faced by Inst/Unit during implementation of study.
6.2. Suggestions for rectifying these problems
6..3. Any Special Achievement
Signature Signature
Investigator incharge of the institute/unit
REPORTING PROFORMA III
INTERIM REPORT
( ( 6 months / 9months / 12 months/2yrs/3yrs ))
(To be submitted to Hqrs.)
|1 |INTRODUCTION |
| |1.1. |Title of the Study: | |
| |1.2. |Name of the Institute/Unit: | |
| |1.3. |Period of Interim Report: | |
| |1.4. |Primary Objective of the Study: | |
| | |To ascertain therapeutic efficacy of Homoeopathic Medicine(s) in the management of Chronic Bronchitis. |
| |1.5. |Secondary Objective of the Study: | |
| | |To ascertain the role of Homoeopathic medicine and to establish verified characteristic symptoms of medicine used. |
| | |To assess the role of homoeopathic medicines in reversing the pathological changes due to Chronic Bronchitis. |
| | |Determine the most useful strategy for management of the differing intensity. |
| | |To check the progression to complications. |
| | |To prevent the relapse. |
| |1.6 |No. of cases Attended O.P.D. |T |M |F |
| | |New | | | |
| | |Old | | | |
| | |Total | | | |
| |1.7 |No. of cases Registered so far since Inception | | | |
| |1.8. |No. of Cases Studied: |T |M |F |
| | | | | | |
| |1.9. |Staff Engaged in the Project: |
| | | |Name |Qualification |Designation |
| | |i) | | | |
| | |ii) | | | |
| | |iii) | | | |
| | |iv) | | | |
| | |v) | | | |
| | | | | | |
| |1.10. |Number of subject presenting with following symptoms and signs: |
| | |Symptoms/ signs |New |Old |
| | | |T |M |F |T |M |F |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |1.11 |Examination findings: | | | | | | |
| |i) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |ii) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |iii) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |iv) | | | | | | | |
| |v) | | | | | | | |
|1.10- pathological findings – |
| | |New |Old |
|1. |X-ray finding- | | |
|2. |PFT- | | |
|3. |any other finding- | | |
|4. | | | |
|5. | | | |
|2- material– |
|2.1- total no. of research cases |
| | |T |M |F |
|1. |Screened | | | |
|2. |included in study | | | |
|3. |Excluded | | | |
|4. |dropped out | | | |
|5. |loss to follow-up | | | |
|6. |Withdrawn | | | |
|2.2- age distribution |
| | |New |Old |
|1. |40-50 yrs | | |
|2. |50-60 yrs | | |
|3. |60-70 yrs | | |
|4. | | | |
|5. | | | |
|2.3- duration of complaints- |
| | |New |Old |
|1. |range- Minimum ______________ | | |
|2. |Maximum ___________________ | | |
|3. |3 months- to less than 6 months | | |
|4. |6 months to less than 1 yr | | |
|5. |1 yr to less than 5 yr | | |
|6. |5 yr to less than 10 yr | | |
|7 |10 yr to less than 15 yr | | |
|8 |15 yr to less than 20 yr | | |
|9 |20 yrs and above | | |
|2.4- predisposition- |
| | |New |Old |
|1. |smoking | | |
|2. |exposure to allergens | | |
| | | | |
| | | | |
|2.5- clinical types of chronic bronchitis | | |
|1. |simple | | |
|2. |mucopurulent | | |
| | | | |
| | | | |
|2.6- baseline information & post treatment - |
| |symptom score |baseline |post treatment |
|1. |10-15 | | |
|2. |16-31 | | |
|3 |32-40 | | |
|2.7- reduction in baseline symptom score after treatment |
| | |T |M |
|1. |more than 1 and less than 5 | | |
|2. |b/w 5 & 6 less than 8 | | |
|3 |more than 8 & less than 10 | | |
|4 |more than 10 & less than 15 | | |
|2.8- improvement in pathological /examination findings- |
| | |Before Treatment |After Treatment |
|1. |decrease in crackles | | |
|2. |change in X-ray finding | | |
|a |normal | | |
|b |abnormal | | |
|3 |changes in PFT | | |
|3- basis of prescription |
| | |New |Old |
|1. |mental symptoms | | |
|2. |physical characteristics | | |
|3 |repertorial totality | | |
|4 | | | |
|3.1- duration of treatment |
| | |New |Old |
|1. |Minimum | | |
|2. |Maximum | | |
|3 |0-3 months | | |
|4 |3-6months | | |
|5 |6-9 months | | |
|6 |9months to 1 yr | | |
|7 |more than 1 year | | |
|3.2- improvement indices— |
|I degree of improvement- |
| | |New |Old |
|1. |Marked | | |
|2. |Moderate | | |
|3 |Mild | | |
| | | | |
|II |Worsened | | |
|III |Static | | |
|IV |Referred for other treatment- | | |
3.3.1.
|Sl. |Name of Drug with Potency |Indication |No. of cases |NO. OF CASES Improvement |
|No. |& Dosage | |Medicine Prescribed | |
| | | | |Mild |Moderate |Marked |
| | | | | | | |
| | | | | | | |
3.3.2.
|Name of Drug |Clinical symptoms improved |No. of cases |
| | | |
| | | |
| | | |
| | | |
4. Relapse
Relapse with intensity Before and After Treatment
|Intensity Before Treatment |Intensity After Treatment |
| |No of Cases |No of Cases Mild |No of Cases Moderate |No of Cases Severe |
|Mild | | | | |
|Moderate | | | | |
|Severe | | | | |
5. Progression to complications.
|Complications |Name of Medicine(s) with potency |No. of cases |
| | | |
| | | |
| | | |
Number of cases referred for other therapy/ clinical failure
|Baseline Score |Duration of Treatment |Score At Time Of Referral |No.of Medicines Used |Age Of Case |
| | | | | |
| | | | | |
| | | | | |
Number of adverse events
| Name of adverse |Duration of Treatment |Management Done |Name of Medicines Used if |Response to Treatment |
|event | | |homoeopathic Management | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
The most useful strategy for management of the differing intensity
6. 6.1. Problems faced by Inst/Unit during implementation of study.
6.2. Suggestions for rectifying these problems
6..3. Any Special Achievement
Signature Signature
Investigator incharge of the institute/unit
REPORTING PROFORMA IV
( ( consolidated report))
(To be submitted to Hqrs.)
|1 |INTRODUCTION |
| |1.1. |Title of the Study: | |
| |1.2. |Name of the Institute/Unit: | |
| |1.3. |Period of Interim Report: | |
| |1.4. |Primary Objective of the Study: | |
| | |To ascertain therapeutic efficacy of Homoeopathic Medicine(s) in the management of Chronic Bronchitis. |
| |1.5. |Secondary Objective of the Study: | |
| | |To ascertain the role of Homoeopathic medicine and to establish verified characteristic symptoms of medicine used. |
| | |To assess the role of homoeopathic medicines in reversing the pathological changes due to Chronic Bronchitis. |
| | |Determine the most useful strategy for management of the differing intensity. |
| | |To check the progression to complications. |
| | |To prevent the relapse. |
| |1.6 |No. of cases Attended O.P.D. |T |M |F |
| | |New | | | |
| | |Followed up | | | |
| | |Total | | | |
| |1.7 |No. of cases Registered so far since Inception | | | |
| |1.8. |No. of Cases Studied: |T |M |F |
| | | | | | |
| |1.9. |Staff Engaged in the Project: |
| | | |Name |Qualification |Designation |
| | |i) | | | |
| | |ii) | | | |
| | |iii) | | | |
| | |iv) | | | |
| | |v) | | | |
| | | | | | |
| |1.10. |Number of subject presenting with following symptoms and signs: |
| | |Symptoms/ signs |New |Old |
| | | |T |M |F |T |M |F |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |1.11 |Examination findings: | | | | | | |
| |i) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |ii) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |iii) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| |iv) | | | | | | | |
| |v) | | | | | | | |
|1.10- pathological findings – |
| | |New |Old |
|1. |X-ray finding- | | |
|2. |PFT- | | |
|3. |any other finding- | | |
|4. | | | |
|5. | | | |
|2- material– |
|2.1- total no. of research cases |
| | |T |M |F |
|1. |Screened | | | |
|2. |included in study | | | |
|3. |Excluded | | | |
|4. |dropped out | | | |
|5. |loss to follow-up | | | |
|6. |Withdrawn | | | |
|2.2- age distribution |
| | |New |Old |
|1. |40-50 yrs | | |
|2. |50-60 yrs | | |
|3. |60-70 yrs | | |
|4. | | | |
|5. | | | |
|2.3- duration of complaints- |
| | |New |Old |
|1. |range- Minimum ______________ | | |
|2. |Maximum ___________________ | | |
|3. |3 months- to less than 6 months | | |
|4. |6 months to less than 1 yr | | |
|5. |1 yr to less than 5 yr | | |
|6. |5 yr to less than 10 yr | | |
|7 |10 yr to less than 15 yr | | |
|8 |15 yr to less than 20 yr | | |
|9 |20 yrs and above | | |
|2.4- predisposition- |
| | |New |Old |
|1. |smoking | | |
|2. |exposure to allergens | | |
| | | | |
| | | | |
|2.5- clinical types of chronic bronchitis | | |
|1. |simple | | |
|2. |mucopurulent | | |
| | | | |
| | | | |
|2.6- baseline information & post treatment - |
| |symptom score |baseline |post treatment |
|1. |10-15 | | |
|2. |16-31 | | |
|3 |32-40 | | |
|2.7- reduction in baseline symptom score after treatment |
| | |T |M |
|1. |more than 1 and less than 5 | | |
|2. |b/w 5 & 6 less than 8 | | |
|3 |more than 8 & less than 10 | | |
|4 |more than 10 & less than 15 | | |
|2.8- improvement in pathological /examination findings- |
| | |Before Treatment |After Treatment |
|1. |decrease in crackles | | |
|2. |change in X-ray finding | | |
|a |normal | | |
|b |abnormal | | |
|3 |changes in PFT | | |
|3- basis of prescription |
| | |New |Old |
|1. |mental symptoms | | |
|2. |physical characteristics | | |
|3 |repertorial totality | | |
|4 | | | |
|3.1- duration of treatment |
| | |New |Old |
|1. |Minimum | | |
|2. |Maximum | | |
|3 |0-3 months | | |
|4 |3-6months | | |
|5 |6-9 months | | |
|6 |9months to 1 yr | | |
|7 |more than 1 year | | |
|3.2- improvement indices— |
|I degree of improvement- |
| | |New |Old |
|1. |Marked | | |
|2. |Moderate | | |
|3 |Mild | | |
| | | | |
|II |Worsened | | |
|III |Static | | |
|IV |Referred for other treatment- | | |
3.3.1.
|Sl. |Name of Drug with Potency |Indication |No. of cases |NO. OF CASES Improvement |
|No. |& Dosage | |Medicine Prescribed | |
| | | | |Mild |Moderate |Marked |
| | | | | | | |
| | | | | | | |
3.3.2.
|Name of Drug |Clinical symptoms improved |No. of cases |
| | | |
| | | |
| | | |
| | | |
4. Relapse
Relapse with intensity Before and After Treatment
|Intensity Before Treatment |Intensity After Treatment |
| |No of Cases |No of Cases Mild |No of Cases Moderate |No of Cases Severe |
|Mild | | | | |
|Moderate | | | | |
|Severe | | | | |
5. Progression to complications.
|Complications |Name of Medicine(s) with potency |No. of cases |
| | | |
| | | |
| | | |
Number of cases referred for other therapy/ clinical failure
|Baseline Score |Duration of Treatment |Score At Time Of Referral |No.of Medicines Used |Age Of Case |
| | | | | |
| | | | | |
| | | | | |
Number of adverse events
| Name of adverse |Duration of Treatment |Management Done |Name of Medicines Used if |Response to Treatment |
|event | | |homoeopathic Management | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
The most useful strategy for management of the differing intensity
6. 6.1. Problems faced by Inst/Unit during implementation of study.
6.2. Suggestions for rectifying these problems
6..3. Any Special Achievement
Signature Signature
Investigator incharge of the institute/unit
-----------------------
Patients who present with cough with scanty or copious mucoid and tenacious expectoration for three months or more for at least two consecutive years,
Presence of
• Cystic fibrosis (E84.-)
• Bronchitis, not specified as acute or chronic (J40)
• Unspecified chronic bronchitis (J42)
• Emphysema (J42)
• Other chronic obstructive pulmonary diseases (J44)
• Asthma (J45)
• Status asthmaticus (J46)
exclusion
No
Written informed consent
Yes, register the case and go for baseline assessment
Selection of medicine within the 14 drugs
No
Exclusion ,treat the case in OPD
Assess the case after 15 days
If no response , go for investigation ,ESR& Xray
Assess the case if no improvement
Change the prescription maximum twice from trial drugs. If no response, refer the case.
| Stannum metallicum, | Arsenicum album, |Silicea, |
|Phosphorus, |Lycopodium |Pulsatilla. |
| Calcarea carb, |Sulphur, |Hepar sulph, |
| Ipecacuanha |Bryonia alba, | Antimonium tartaricum |
| Carbo vegetables, | Spongia tosta, | |
................
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