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Session 2: Clinical studies and clinical application of traditional & indigenous medicine

The Safety and Immunostimulatory Effect of Triphala Extract in

Thai Healthy Volunteers.

Pratya Phetkate*, Tanawan Kummalue**, Yaowalak U-pratya***,
Somboon Kietinun*
*Chulabhorn International College of Medicine, Thammasat University, Pathumthani 12120, Thailand
**Department of Clinical Pathology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok
10700, Thailand
***Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol
University, Bangkok 10700, Thailand

Background and Rationale: HIV/AIDS is one of the biggest challenges we face today as
a country. The incidence of HIV/AIDS is rising rapidly and there are over 36.9 million people
living with HIV in 2014. It is a disease that destroys the patientûs ability to fight against the
infections through the immune system. So it is urgent to find the medication for improving the
immunity of HIV/AIDS positive people. One of the foremost formulas in Thai Traditional Medi-
cine is Triphala, which is effective, and has been recommended to be used for improving
immunity and balancing health. Previous report showed Triphala (a Thai traditional foremost
formula) had the immunomodulatory effect in mice but it has not been investigated yet for
immunostimulatory and side effects in healthy human volunteers.
Objective: This study sought to examine the efficacy on immunity and safety of Triphala
extract in a clinical phase I study.
Methods: In this study all assigned volunteers took Triplala extract 3 capsules per day
for 2 weeks, with measurement taken at the baseline and at the end of every week, for 2 weeks
during medication and another 2 weeks after finishing medication by complete physical
examination, routine laboratory analysis (hematology, liver function, renal function), and
immunological analysis.
Results: This study showed that Triphala extract demonstrated significant immuno-
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stimulatory effects on cytotoxic T cells (CD3 CD8 ) and natural killer cells (CD16 CD56 ) when
compared with those of the control samples and had no obvious adverse effect.
Conclusion: Triphala extract has significant immunostimulatory effects on cellular im-
mune response, especially cytotoxic T cells and natural killer cells. Increases in the absolute
number of these cells may improve immunity of people living with HIV/AIDS.
Key words: HIV, AIDS, Triphala, immunomodulatory effect, side effect, clinical trial
phase I