India and UK to conduct clinical trials of Ashwagandha for promoting COVID-19 recovery

The Ministry of Ayush has collaborated with the UK’s London School of Hygiene and Tropical Medicine (LSHTM) to conduct a study on Ashwagandha for promoting recovery from COVID-19, a statement has said.

It also said that the All India Institute of Ayurveda (AIIA), an autonomous body under the Ministry of Ayush and LSHTM recently signed a Memorandum of Understanding (MoU) to conduct clinical trials of Ashwagandha on 2,000 people in three UK cities – Leicester, Birmingham and London (Southall and Wembley).

Ashwagandha (Withania somnifera), commonly known as ‘Indian winter cherry,’ is a traditional Indian herb that boosts energy, reduces stress and makes the immune system stronger. It is an easily accessible, over-the-counter nutritional supplement in the UK and has a proven safety profile. The positive effects of Ashwagandha have been observed in long COVID, which is a multi-system disease with no evidence of its effective treatment or management, according to the statement.

It also mentioned that the successful completion of the trial can be a major breakthrough and give scientific validity to India’s traditional medicinal system. While there have been several studies on Ashwagandha to understand its benefits in various ailments, this is the first time the Ministry of Ayush has collaborated with a foreign institution to investigate its efficacy on COVID-19 patients.

Further, according to Dr Tanuja Manoj Nesari, Director, AIIA, who is also a co-investigator in the project, along with Dr Rajgopalan, Coordinator – International Projects, the participants have been randomly selected. Dr Sanjay Kinra from LSHTM is the principal investigator of the study.

“For three months, one group of 1,000 participants will be administered Ashwagandha (AG) tablets while the second group of 1,000 participants will be assigned a placebo, which is indistinguishable from AG in looks and taste. Both patients and the doctors will be unaware of the group’s treatment in a double-blind trial,” Dr Nesari said.

The participants will have to take the 500 mg tablets twice a day. A monthly follow-up of self-reported quality of life, impairment to activities of daily living, mental and physical health symptoms, supplement use and adverse events will be carried out, added the statement.

It took over 100 meetings spanning about 16 months through both diplomatic as well as regulatory channels for the signing of the MoU, Dr Nesari said. She added that the study has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and certified by WHO-GMP. It is being conducted and monitored as per the internationally-recognised GCP (Good Clinical Practices) guidelines, she added.

Recently, a number of randomised placebo-controlled trials of AG in humans in India have demonstrated its efficacy in reducing anxiety and stress, improving muscle strength and reducing symptoms of fatigue in patients treated for chronic conditions. It has also been indicated for treating non-restorative sleep, a hallmark of chronic fatigue, for which the trials are currently ongoing. Combined with substantial literature on its pharmacological and immuno-modulatory effects in vitro and in animals, the study suggests Ashwagandha as a potential therapeutic candidate for alleviating the long-term symptoms of COVID-19, the statement notified.