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.

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Background and objective: Qufushengji powder is a classical external medicine in Chongqing Orthopaedic Hospital of Traditional Chinese Medicine for surgical ulcer. This trial is designed to demonstrate the safety and efficacy of Qufushengji powder for treatment of diabetic foot ulcers. Participants and methods: This is a parallel randomized controlled trial, which will be conducted at Chongqing Orthopaedic Hospital of Traditional Chinese Medicine, China. The included patients with moderate to severe diabetic foot ulcers will be randomly divided into control group and intervention group. Patients in the control and intervention groups will be sterilely bandaged with Kangfuxin solution and applied gauze strips of Qufushengji powder based on conventional therapy. In the study execution time of each stage, patient recruitment began in June 2020. The analysis of primary outcome measure will be completed in July 2021, and the study will be finished in May 2022. The protocol was approved by the Ethics Committee for Research Involving Human Subjects from Chongqing Orthopedics Hospital of Traditional Chinese Medicine on May 24, 2019 (approval No. 2019-17). Outcome measures: Ulcer healing rate after 12 weeks of treatment is primary outcome measure. Secondary outcome measures include relief of local foot symptoms, functional recovery and adverse events. Discussion: Results of this trial will provide preliminary evidence for the use of Qufushengji powder in the clinical treatment of diabetic foot ulcers. Trial registration: This trial was registered in the Chinese Clinical Trial Registry on April 25, 2020 (registration number: ChiCTR2000032315).

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