A standardised ashwagandha root extract was found to be well tolerated when administered daily for 24 weeks, with no evidence of treatment-related liver or kidney injury, according to a large multicentre clinical trial published in "Frontiers in Medicine".

The randomised, double-blind, placebo-controlled study, published on August 20, involved 1,200 apparently healthy adults aged 18 to 70 years who had received a first, second or booster dose of the COVISHIELD vaccine.

The study, titled "Safe prolonged prophylactic use and tolerability of Ashwagandha following COVISHIELD vaccination over 24 weeks: a multicentre randomised double-blind placebo-controlled trial" was published in "Frontiers in Medicine", Volume 13.

Conducted across seven sites in India, the study brought together 45 researchers from nine institutions, including the Central Council for Research in Ayurvedic Sciences (CCRAS), All India Institute of Ayurveda, National Institute of Ayurveda, Jaipur, Ayush Centre of Excellence, Translational Health Science and Technology Institute and Savitribai Phule Pune University.

Participants were randomly assigned to receive either 500 mg of a standardised aqueous ashwagandha root extract daily, equivalent to four grams of raw root powder, or a matching placebo.

The intervention was administered for 24 weeks, with participants followed until week 28. Of the 1,200 participants enrolled, 1,032 (86 per cent) completed the study.

The researchers assessed liver and kidney function through parameters, including liver enzymes, bilirubin, creatinine and blood urea.

The study reported that these parameters remained within the stated reference ranges, with no evidence of treatment-related hepatic or renal injury.

No serious adverse events were considered attributable to the study intervention and no participant withdrew from the trial because of an adverse event, according to the researchers.

The study also assessed whether prolonged administration of ashwagandha extract affected the immune response following the COVISHIELD vaccination.

Virus-neutralising activity exceeded 85 per cent in both the ashwagandha and placebo groups, with no statistically significant difference between them, suggesting that the intervention did not interfere with vaccine-induced immunity, the researchers said.

Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, said the findings contribute to the scientific evidence on the safety and appropriate use of standardised Ayurveda interventions.

"High-quality clinical research strengthens the scientific evidence-base of Ayurveda and contributes to a deeper understanding of its potential within contemporary healthcare. The growing body of evidence from rigorous clinical studies is also supporting the responsible global utilisation of Ayurveda and its interventions across health and wellness settings," he said.

Dr Arvind Chopra, Ayush Distinguished Scientist Chair, Director and Chief Rheumatologist at the Centre for Rheumatic Diseases, Pune, and the lead author of the study, said the trial provided evidence on the safety and tolerability of standardised ashwagandha over 24 weeks.

"Throughout the study, liver and kidney function parameters remained within physiological reference ranges, with no treatment-related liver or kidney injury observed," he said.

The study also demonstrated that ashwagandha did not interfere with vaccine-induced immunity, Chopra said, adding that high levels of neutralising activity were maintained in both groups.

Prof Bhushan Patwardhan, National Professor of Ayush and co-author, said the study demonstrated how Ayurveda could be evaluated through contemporary clinical research while retaining its traditional foundations.

"The favourable safety and tolerability findings over 24 weeks add to the clinical evidence on standardised ashwagandha preparations and underline the importance of evidence-based approaches for their responsible integration into healthcare," he said.

Vaidya Rabinarayan Acharya, Director General, CCRAS, said well-designed clinical studies were important for strengthening the evidence base of Ayurveda and supporting the responsible use of standardised Ayurvedic preparations.

The trial was registered with the Clinical Trials Registry-India.

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