Safety and tolerability assessment of Shoden, the Ashwagandha extract standardised with withanolide glycosides: An open label study in healthy volunteers

Background Ashwagandha ( Withania somnifera ) is a traditional herbal remedy known for its adaptogenic properties. Shoden®, a novel extract of Ashwagandha standardised with withanolide glycosides, is gaining attention for its potential health benefits. Objectives This study aims to assess the safety and tolerability of Ashwagandha extract enriched with 35% withanolide glycosides (Shoden®) in healthy participants. Materials and methods An open-label study was conducted with 62 healthy participants, administered 480 mg/day of the test Ashwagandha extract for 90 days. Hematology, lipids profile, liver and renal function tests, urine analysis and vitals were evaluated on Day 30, 60 and 90 against baseline. Participants were also monitored for adverse effects. Results Safety parameters remained stable with no clinically significant deviations from baseline. No significant variability was noted in body weight or vital parameters. The extract did not show significant variability in the blood sugar, ESR, serum cholesterol, and renal function indicators among the participants across the trial period. No significant variability of liver enzyme activity was observed following Ashwagandha administration. Conclusion Daily intake of 480 mg of test Ashwagandha extract standardised with 35% withanolide glycosides for 90 days was found to be safe and well-tolerated, supporting its use for general well-being.