Ashwagandha Trial Finds No Liver or Kidney Injury

• Trial involved 1,200 adults across seven sites in India.
• Participants received 500 mg Ashwagandha root extract daily for 24 weeks.
• Researchers found no treatment-related liver or kidney injury.
• Study reported no interference with COVISHIELD-induced immunity.

GG News Bureau
New Delhi, 28th Sept: A multicentre randomised, double-blind, placebo-controlled clinical trial has reported that daily administration of a standardised Ashwagandha root extract for 24 weeks was well tolerated, with no evidence of treatment-related liver or kidney injury.

The study, published in Frontiers in Medicine on August 20, 2026, evaluated the safety and tolerability of a standardised aqueous Ashwagandha root extract among 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 conducted by a multidisciplinary team of 45 researchers from nine institutions.

The participating institutions included 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, Centre for Complementary and Integrative Health and Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, among others.

The trial was conducted at seven study sites in India and included clinical, laboratory and immunological assessments. It was registered with the Clinical Trials Registry–India under registration number CTRI/2021/06/034496.

Participants followed for 24 weeks
The participants were randomly assigned to receive either 500 mg of a standardised aqueous Ashwagandha root extract daily, equivalent to 4 grams of raw root powder, or a matching placebo.

The intervention was administered for 24 weeks, with participants followed through week 28. Of the 1,200 participants enrolled in the trial, 1,032, or 86 per cent, completed the study.

According to the study findings, the standardised Ashwagandha root extract showed a favourable safety and tolerability profile during the 24-week intervention period.

Liver and kidney function parameters remained within the reported reference ranges. The assessments included liver enzymes, bilirubin, creatinine and blood urea, with researchers reporting no evidence of treatment-related hepatic or renal injury.

The study also reported that no serious adverse events were considered attributable to the intervention. No participant withdrew from the trial because of an adverse event.

Immune response also assessed
The researchers additionally examined whether 24-week administration of the standardised Ashwagandha root extract affected the immune response following COVISHIELD vaccination.

Virus-neutralising activity exceeded 85 per cent in both the Ashwagandha and placebo groups. The study reported no statistically significant difference between the two groups.

The researchers said these findings indicated that the intervention did not interfere with vaccine-induced immunity among the participants studied.

Ayush Ministry highlights clinical evidence
Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, said the findings contribute to the scientific evidence concerning 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,” he said.

Kotecha added that the growing body of evidence from rigorous clinical studies was supporting the responsible global utilisation of Ayurveda and its interventions across health and wellness settings.

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 the trial provided evidence on the safety and tolerability of standardised Ashwagandha over 24 weeks.

He noted that liver and kidney function parameters remained within physiological reference ranges throughout the study and that no treatment-related liver or kidney injury was observed.

Chopra also highlighted the findings concerning vaccine-induced immunity, stating that high levels of neutralising activity were maintained in both the Ashwagandha and placebo groups.

Researchers stress importance of standardised preparations
Prof. Bhushan Patwardhan, National Professor of Ayush and co-author of the study, described the trial as an example of evaluating Ayurveda through contemporary clinical research while retaining its traditional foundations.

He said the favourable safety and tolerability findings over 24 weeks added to the clinical evidence concerning standardised Ashwagandha preparations and highlighted the importance of evidence-based approaches to their use in healthcare.

Prof. (Vaidya) Rabinarayan Acharya, Director General, CCRAS, said the findings provided evidence on the safety and tolerability of a standardised Ashwagandha root extract when administered under controlled conditions for 24 weeks.

He emphasised that well-designed clinical studies are important for strengthening the scientific evidence base of Ayurveda and supporting the evidence-informed use of standardised Ayurvedic preparations.

The study’s findings add to the clinical evidence on the safety and tolerability of the specific standardised Ashwagandha root extract and dosage studied over the 24-week trial period.