A Proposed Phase I, Randomized Controlled Study to ...

A Proposed Phase I, Randomized Controlled Study to Determine Whether a Combination of Ginger, Turmeric, and Sage Can Reduce C-Reactive Protein in Subjects Undergoing HIV Highly

Active Anti-Retroviral Therapy

By Kyle Burton, L.Ac.

A Capstone Project Presented in partial fulfillment of the requirement for the

Doctor of Acupuncture and Oriental Medicine Degree

Capstone Project Advisor: Rosaleen Ostrick Yo San University

Los Angeles, California March 2017

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Signature Page

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Abstract Highly active anti-retroviral therapy (HAART) has increased the life expectancy of the HIVpositive patients similar to that of the HIV-negative population. However, those undergoing HAART have shown an increased chance for cardiovascular disease (CVD). Higher levels of CReactive Protein (CRP), a risk factor for CVD, are more common for those with HIV. Since HAART is essential for suppressing the viral load, this pilot study will test the safety of adding an herbal formula in combination with HAART to help reduce CRP and potentially CVD. Turmeric, ginger, and sage have been shown to decrease inflammation and do not have any known negative interactions with HAART's absorption or efficacy. Method: Patients undergoing HAART will be randomized into either an intervention group that will be given 3 grams of the herbal formula twice a day, or into a control group. The trial will last for six weeks. Results: Introductory and final blood draws will be compared to determine whether a significant change in CRP or viral levels occurred. The standard risk factors for CVD will also be tested including: glucose, cholesterol, blood pressure, and weight. The results will show if this herbal combination can safely and effectively reduce the increased risk of CVD in those undergoing HAART.

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Acknowledgments

Many people helped make this paper possible; the staff at Yo San University for their overwhelming support, Dr. Laraine Crampton and Dr. Andrea Murchison for their excellent guidance, Dr. Spar and his expertise, and my aunt, Penny Haddad for her life time of inspiration. A special thank you to my family and office staff for their continual support and to my advisor, Rosaleen Ostrick, whom none of this would be possible. Thank you to my fellow cohort for their friendship, humor, and encouragement.

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Table of Contents

Signature Page...............................................................................2

Abstract.......................................................................................3

Acknowledgments...........................................................................4

Chapter One: Introduction..................................................................7

Purpose..............................................................................8 Research Question..................................................................8 Hypothesis...........................................................................8 Null Hypothesis.....................................................................8 Value of Study......................................................................8 Definition of Terms................................................................9

Chapter Two: Literature Review.........................................................11

Overview...........................................................................11 Inflammation......................................................................11

Acute vs Chronic.........................................................12 Cardiovascular Disease..........................................................12 Inflammatory Enzymes Cyclooxygenase .....................................14 Inflammatory Proteins: CRP ....................................................14 Inflammatory Cytokines: TNF-alpha, IL-6 ...................................15 How CRP Can Increase Risk for CVD........................................15 CRP vs. Highly Sensitive CRP Lab Work....................................17 Standard of Care Treatment for Inflammation................................17 Diet and CRP......................................................................18 HIV / AIDS........................................................................19 Highly Active Anti-Retroviral Therapy (HAART)...........................19 HAART, HIV and Inflammation................................................21 Other Comorbidities..............................................................21 Traditional Chinese Medicine and Thermal Properties.......................23 Ginger..............................................................................24 Sage.................................................................................26 Turmeric...........................................................................27 Herb / Drug Interactions..........................................................28 Research Synthesis................................................................29

Chapter Three: Methodology............................................................30

Design..............................................................................30 Sampling Procedures ............................................................31 Search Terms.....................................................................31

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