How new safety evidence is boosting India’s expanding Ashwagandha market

As the use of Ashwagandha expands in India and global markets, a large clinical trial backed by the Ministry of Ayush has found that a standardised Ashwagandha root extract was well tolerated when taken daily for 24 weeks, with no treatment-related liver or kidney injury reported.

Ashwagandha, traditionally used in Ayurveda, has become a widely marketed ingredient in herbal and health products in India and overseas.

The researchers noted that, despite its widespread use, controlled clinical evidence on prolonged use remains limited.

The findings come as the global Ashwagandha market expands. Grand View Research estimates the Indian Ashwagandha supplements market at about ₹657 crore ($68.4 million) in 2025, and projects it to reach ₹1,421 crore ($148 million) by 2033. Globally, Mordor Intelligence estimates the Ashwagandha market at about ₹7,296 crore ($760 million) in 2025, with the market projected to reach ₹11,328 crore ($1.18 billion) by 2030.

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The study, involving 1,200 vaccinated adults across seven centres in India, was conducted against the backdrop of the Covid-19 vaccination programme. Researchers wanted to assess the safety of prolonged Ashwagandha use after vaccination and whether it had any effect on the immune response generated by the Covishield vaccine.

Published in Frontiers in Medicine on August 20, the trial randomly assigned participants to receive either 500 mg a day of a standardised aqueous Ashwagandha root extract, equivalent to 4 grams of root powder, or a placebo designed to look like the treatment but containing no Ashwagandha. Neither participants nor researchers knew who was receiving which treatment during the trial. Participants were followed for 28 weeks, including 24 weeks of treatment.

Of the 1,200 participants enrolled, 1,032 or 86% completed the study. Blood tests used to assess liver and kidney function remained within the reported reference ranges, with no evidence of injury linked to the Ashwagandha extract.

The trial also found no additional immune benefit from Ashwagandha after Covishield vaccination. Neutralising antibody levels, which indicate the body's ability to block the virus, remained high in both groups, with no statistically significant difference between them.

The study recorded 337 adverse events among participants receiving Ashwagandha and 309 among those receiving the placebo. Most were mild to moderate and mainly involved the digestive system. Eight serious adverse events were reported, six in the Ashwagandha group and two in the placebo group, but none was considered related to the treatment. No participant withdrew because of an adverse event, and there were no deaths.

Dr Arvind Chopra, lead author and Director and Chief Rheumatologist at the Centre for Rheumatic Diseases, Pune, said the study provided evidence on the safety and tolerability of the extract over 24 weeks.

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The study's findings apply to the specific standardised aqueous root extract and dose tested in apparently healthy adults aged 18 to 70 years. They do not establish that all Ashwagandha products are safe or that the herb is effective for conditions such as stress, anxiety, or sleep problems. Further controlled studies would be needed to assess its potential benefits for specific conditions and populations.

For the Ministry of Ayush, the study adds to the clinical evidence around the safety and responsible use of Ayurvedic preparations. Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, said, "Rigorous clinical research could strengthen the scientific evidence base for Ayurveda and support the responsible use of its interventions."

The study was conducted by 45 researchers from nine institutions, including the Central Council for Research in Ayurvedic Sciences, All India Institute of Ayurveda, National Institute of Ayurveda, Jaipur, Ayush Centre of Excellence and Translational Health Science and Technology Institute. The trial was registered with the Clinical Trials Registry-India.