Analysis of Clinical Trial Registry of India for Evidence of Anti-Arthritic Properties of Withania somnifera (Ashwagandha).

Background: Withania somnifera (Ashwagandha) is an herb with anti-inflammatory properties used in managing arthritis. There is significant clinical data in the public domain on the effects of Ashwagandha and this study was aimed at compiling and analysing these data in a structured manner. The major sources of evidence data were clinical trials and systematic review of extant literature.Methodology: Retrospective database search was conducted in the Clinical Trial Registry of India for trials registered from April 2008 to March 2020, and published literature related to the anti-arthritic effects of Withania somnifera were reviewed.Results: In all, 77 registered clinical trials were analysed and common among them were interventional, single-centre, randomized, double-blind, two-arm studies with Placebo being the comparator. Similar findings were observed in the 10 published clinical trials on arthritis evaluated for this study. While industry- and government-sponsored trials were identified, government funded sites with approvals from Institutional Ethics Committees were preferred. Most trials were registered as Phase 2 with the highest number of sites in the state of Maharashtra. The solid dosage form was most preferred.Conclusion: While the effects of Withania somnifera on various disorders are being investigated by several clinical trials, the ones evaluated for this study provide insight on its potential in managing arthritis when given for a specific duration. Evidence shows a dosage of 6 gm in powder form or extracts in tablets, or 500 -1000 mg capsule consumed for a duration of 8 - 12 weeks may be useful in managing symptoms of arthritis in patients.