Efficacy and safety of freeze-dried form of Tragia involucrata L. decoction in treating diabetes: a randomized controlled clinical trial

Abstract

Background and objectives: Tragia involucrata L. (Family: Euphorbiaceae, S. Wel Kahambiliya) is a highly used medicinal plant in both systems of Sri Lankan traditional medicine and Ayurveda medicine. This plant is used for the treatment of diseases such as diabetes, wounds, dysuria, and epilepsy. The aim of this study was to evaluate the efficacy and safety of the freeze-dried form of Tragia involucrata L. decoction in the treatment of diabetes. Subjects and methods: This randomized, two-arm, open-label, controlled clinical trial was conducted in type 2 diabetes patients at National Ayurveda Teaching Hospital in Colombo, Sri Lanka during the year 2016–2017. Thirty-six type 2 diabetes patients aged 18–70 years were included in each group. Patients received treatment with 120 mL of Tragia involucrata L. decoction and 500 mg of metformin, twice a day, for 14 days used as the test drug and positive control drug groups. Fasting blood glucose level was measured on days 0, 8, and 15. Lipid profile and liver and kidney functions were measured on days 0 and 15. This study was approved by the Ethics Review Committee, Institute of Indigenous Medicine (ERCIIM), University of Colombo, Rajagiriya, Sri Lanka (approval No. ERC 16/61) on October 27, 2016. Results: Fasting blood glucose levels in the test group were significantly decreased on days 8 and 15 compared to day 0 (P < 0.05). There was no significant change in the lipid profile values before and after treatment (P > 0.05). Also the decoction did not cause changes in the function of the liver and kidneys. Further no other adverse reactions were recorded in the patients. Conclusion: Tragia involucrata L. can reduce fasting blood glucose level and has antidiabetic effects in diabetes.