24 Weeks of Ashwagandha Showed No Liver or Kidney Injury in Clinical Trial

A multicentre clinical trial published in Frontiers in Medicine has found that daily use of a standardised Ashwagandha root extract for 24 weeks was well tolerated, with no evidence of treatment-related liver or kidney injury, the Ministry of Ayush said on Monday.

The study, published on August 20, was a randomised, double-blind, placebo-controlled trial that evaluated the safety and tolerability of prolonged use of a standardised Ashwagandha root extract following COVISHIELD vaccination.

According to the ministry, participants maintained a favourable safety and tolerability profile throughout the 24-week intervention period. Liver and kidney function parameters remained within the reported reference ranges, with assessments covering liver enzymes, bilirubin, creatinine and blood urea.

The study found no evidence of treatment-related hepatic or renal injury. The ministry also said that no serious adverse events were considered attributable to the intervention and no participant discontinued the trial because of an adverse event.

The research involved 1,200 apparently healthy adults aged between 18 and 70 years who had received either a first, second or booster dose of the COVISHIELD vaccine.

A multidisciplinary team of 45 researchers from nine institutions conducted the study across seven sites in India. Nearly 86 per cent of the participants completed the study.

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. The study included clinical, laboratory and immunological assessments and involved experts from Ayurveda, clinical medicine, rheumatology, complementary and integrative health and related disciplines.

The trial also examined whether the Ashwagandha extract affected the immune response following COVISHIELD vaccination.

Virus-neutralising activity remained above 85 per cent 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 in Pune and lead author of the study, said the findings indicated that Ashwagandha did not interfere with vaccine-induced immunity.

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

The ministry said rigorous clinical research could contribute to a better understanding of Ayurveda-based interventions and support their responsible use in health and wellness settings.