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Journal of Integrative Medicine ›› 2020, Vol. 18 ›› Issue (1): 35-40.doi: 10.1016/j.joim.2019.10.002

• Original Clinical Research • Previous Articles     Next Articles

Study of the safety of oral Triphala aqueous extract on healthy volunteers

Pratya Phetkatea, Tanawan Kummalueb, Prasob-orn Rinthongc, Somboon Kietinuna, Kusuma Sriyakula   

  1. a. Graduate Program in Integrative Medicine, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani 12120, Thailand
    b. Department of Clinical Pathology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
    c. Pharmaceutical Chemistry and Natural Products Research Unit, Faculty of Pharmacy, Mahasarakham University, Maha Sarakham 44150, Thailand
  • Online:2020-01-15 Published:2019-12-02

Background

Triphala extract is a well known medicinal herbal formula which is usually prescribed by Thai traditional doctors to adjust the physiological functions of the body. Previous studies have reported that Triphala has antioxidant, anti-inflammatory, antihypercholesterolemia and anticancer properties. Though this herbal recipe is commonly used in Thailand, its human safety, especially in the oral form, has not been studied. We therefore conducted a clinical trial (Phase I).


Objective

This study evaluated the safety of administering the aqueous extract of Triphala to healthy volunteers at 2500 mg/d.


Design, setting, participants and interventions

An open-label, single-arm trial was conducted at Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand, between July 2017 and July 2018. The study enrolled 10 male and 10 female healthy volunteers; all were given Triphala (water extract; five capsules of 500 mg each) orally, once a day, at bedtime, for four consecutive weeks.


Main outcome measures

Signs and symptoms, physical examinations, hematology and blood chemistry were assessed at the beginning of the trial and every week thereafter, for four consecutive weeks. After finishing the trial, on day 28, all volunteers were invited to a follow-up session on day 35 to evaluate the safety of the herbal recipe using the same measurements.


Results

At the oral dose of 2500 mg/d, Triphala had no serious adverse effects in healthy volunteers. Moreover, it was found to have significantly improved the volunteers’ high-density lipoprotein cholesterol (HDL-C) levels on day 35 and also reduced their blood sugar levels on days 14 and 35.


Conclusions

We conclude that aqueous extract of Triphala is safe for healthy volunteers and that it elevates HDL-C levels and lowers blood sugar. Further clinical study should investigate its effects on HDL-C and blood sugar levels among the dyslipidemic and prediabetic groups.


Trial registration

This trial was registered in the Thai Clinical Trial Registry with the identifier TCTR20180423002.

Key words: Triphala, Clinical trial, Safety, Healthy volunteers

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