ABSTRACT
BACKGROUND: Withania somnifera (L.) Dunal, known as Ashwagandha, is an adaptogen with significant importance in Ayurveda for its potential health benefits in strength ('balavardhan') and muscle growth ('mamsavardhan'). Despite numerous studies on its efficacy, limited research is reported on its clinical safety and tolerability in healthy individuals. OBJECTIVE: This research evaluated the tolerability and safety of standardized Withania somnifera root extract (WSE) capsules (AgeVel®/Witholytin®) at 1000 mg/day dose upon oral administration in healthy male participants. METHOD: A non-randomized, open-label, single-treatment clinical study included eighteen healthy male participants aged 18 to 60. The participants were administered a dose of 500 mg of the WSE capsules twice daily for four weeks. Each capsule contained not less than 7.50 mg of total withanolides. The study evaluated various indicators in a cohort of healthy participants throughout the trial, including vital signs, organ function tests, urine analysis, X-ray and ECG, cardiorespiratory endurance, body fat percentage, lean body weight, adverse events profile, and tolerability of the WSE capsules. RESULTS: The participant's physical, hematological, and biochemical characteristics were normal, and no significant alterations or irregularities were observed in safety metrics like liver, kidney, and thyroid functions after administering AgeVel®/Witholytin®. CONCLUSION: This study found that healthy male participants could consume a standardized WSE at a daily dosage of 1000 mg for four weeks without any adverse effects. Future research should focus on long-term safety assessments in male and female participants.
ABSTRACT
Background: Diabetes is prevalent globally; India stands amongst the first two countries with the highest percentage of adults aged 20-79 years with diabetes in 2021. Anti-diabetic agents and insulin offer profound side effects. Phytoconstituents regulate blood sugar, improve health status and reduce dependency on anti-diabetic medications. This research aims to generate clinical evidence of Diabetic Support Product (GP/PROD/2021/001) in the treatment of type 2 diabetes. Trial design: A randomized, double-blind, placebo-controlled clinical trial was conducted on 150 individuals with type 2 diabetes mellitus. Subjects were divided into two parallel groups and given either GP/PROD/2021/001 or a placebo tablet; 2 tablets twice a day after meals for 90 days. Methods: Interventions were adjuvant to the standard medication. The research objectives were to evaluate changes in fasting and post-meal plasma glucose and HbA1c in patients with type 2 diabetes. Results: In 90 days, GP/PROD/2021/001 group showed a substantial improvement in all key biochemical markers-HbA1c, FBS, and PPBS when compared to the placebo group. A reduced HOMA-IR score suggests reduced insulin resistance. Quality of life improved in GP/PROD/2021/001 group than placebo. On day 90, there was a significant decrease in HbA1c levels in GP/PROD/2021/001 (23.51%) group than placebo (6.21%). The test group reduced their dependency on conventional antidiabetic medication and insulin. Conclusion: It can be concluded from the study that the advanced diabetic support formula (GP/PROD/2021/001) is a safer and more effective option as an adjuvant in the management of diabetes from newly diagnosed to chronic diabetic patients. Trial registration: CTRI/2022/01/039179 [Registered on: 05/01/2022] Trial Registered Prospectively.
