Ashwagandha Herb Found Safe For Liver, Kidney In 24-Week Study

A 24-week multicentre clinical trial involving 1,200 adults has found no evidence of liver or kidney injury linked to a standardised Ashwagandha root extract, with researchers reporting that the preparation was well tolerated during the study.

The study “Safe prolonged prophylactic use and tolerability of Ashwagandha following COVISHIELD™ vaccination over 24 weeks: a multicentre randomised double-blind placebo-controlled trial,” published in Frontiers in Medicine, assessed the safety and tolerability of daily Ashwagandha use for 24 weeks in apparently healthy adults who had received a first, second or booster dose of COVISHIELD vaccination.

Participants aged 18 to 70 were randomly assigned to receive either 500mg of a standardised aqueous Ashwagandha root extract daily, equivalent to 4gm of raw root powder, or a matching placebo. They were followed for another four weeks after the 24-week treatment period. Of the 1,200 participants enrolled, 1,032, or 86%, completed the study.

The researchers monitored liver and kidney function through laboratory tests, including liver enzymes, bilirubin, creatinine and blood urea. The parameters remained within the reported reference ranges, with no evidence of treatment-related hepatic or renal injury.

No serious adverse event was considered related to the study intervention, and no participant withdrew from the trial because of an adverse event.

The study also assessed whether Ashwagandha affected the immune response following COVISHIELD vaccination. Virus-neutralising activity remained above 85% in both the Ashwagandha and placebo groups, with no statistically significant difference between them.

Dr Arvind Chopra, Ayush Distinguished Scientist Chair and Director and Chief Rheumatologist at the Centre for Rheumatic Diseases, Pune, and lead author of the study, said, “This large, multicentre, randomised clinical trial provides important 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.

The study also demonstrated that Ashwagandha did not interfere with vaccine-induced immunity, with high levels of neutralising activity maintained across both the Ashwagandha and placebo groups. These findings reinforce the importance of evaluating standardised Ayurvedic preparations through rigorous, well-controlled clinical research.”

The researchers said the findings add to the clinical evidence on the safety of standardised Ashwagandha preparations, while stressing the need for further well-controlled studies.

Vaidya Rajesh Kotecha, Secretary, Union Ayush Ministry, said, “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.”

The randomised, double-blind, placebo-controlled trial was conducted across seven centres in India by a team of 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.

Prof. Bhushan Patwardhan, National Professor of Ayush and co-author, said, “This study is an important example of how Ayurveda can be evaluated through robust, contemporary clinical research without losing sight of 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.”

At the same time, Prof (Vaidya) Rabinarayan Acharya, Director General, CCRAS, said, “Such well-designed clinical studies are important for strengthening the scientific evidence base of Ayurveda and for supporting the responsible and evidence-informed use of standardised Ayurvedic preparations.”

The study involved a specific standardised aqueous ashwagandha root extract, and its findings therefore relate to the preparation and dose tested in the trial. The results cannot automatically be extended to all Ashwagandha products, formulations or doses, said the researchers.

They also noted that the study population comprised apparently healthy adults who had received the COVISHIELD vaccination. Further studies would be required to assess safety and effectiveness in different patient groups and over longer periods.