Original Research Article Study of the safety of oral Triphala aqueous extract on healthy volunteers Pratya Phetkate a , Tanawan Kummalue b , Prasob-orn Rinthong c , Somboon Kietinun a , Kusuma Sriyakul a,⇑ 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 article info Article history: Received 23 January 2019 Accepted 17 May 2019 Available online xxxx Keywords: Triphala Clinical trial Safety Healthy volunteers abstract 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 vol- unteers 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 choles- terol (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. Please cite this article as: Phetkate P, Kummalue T, Rinthong P-o, Kietinun S, Sriyakul K. Study of the safety of oral Triphala aqueous extract on healthy volunteers. J Integr Med. 2019; xx(x): xxx–xxx Ó 2019 Shanghai Changhai Hospital. Published by ELSEVIER B.V. 1. Introduction Triphala is a herbal formulation commonly used throughout East Asia; it originated in India and its use has been documented since ancient times [1,2]. Triphala is composed of three medicinal fruits in equal proportions: Terminalia chebula Retz., Terminalia bel- lirica Roxb. and Phyllanthus emblica Linn [3]. According to the Thai list of herbal medicinal products of 2011, Triphala powder is pre- scribed as a cough remedy, with a dosage of 1–2 g per 200 mL of warm water [2]. Folk healers have described the use of Triphala as an important health tonic for detoxification, rejuvenation and balancing the elements of the body (earth, water, wind, and fire), especially during summer [4]. The major active constituents of Tri- phala are gallic acid, tannin, ellagic acid and ascorbic acid [5,6]. Previous scientific studies of Triphala have reported that it pos- sesses antioxidant [7–10], antihypercholesteremic [11,12], antidia- https://doi.org/10.1016/j.joim.2019.10.002 2095-4964/Ó 2019 Shanghai Changhai Hospital. Published by ELSEVIER B.V. ⇑ Corresponding author. E-mail address: kusuma-s@tu.ac.th (K. Sriyakul). Journal of Integrative Medicine xxx (xxxx) xxx Contents lists available at ScienceDirect Journal of Integrative Medicine journal homepage: www.jcimjournal.com/jim www.journals.elsevier.com/journal-of-integrative-medicine Please cite this article as: P. Phetkate, T. Kummalue, P. o. Rinthong et al., Study of the safety of oral Triphala aqueous extract on healthy volunteers, Journal of Integrative Medicine, https://doi.org/10.1016/j.joim.2019.10.002