“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,’’ the Ministry said.
“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 was quoted as saying by The Hindu.
The participants will have to take the 500mg 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.
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 had been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) and certified by WHO-GMP. It was being conducted and monitored as per the internationally recognised GCP (Good Clinical Practices) guidelines, she added.
Combined with substantial literature on its pharmacological and immunomodulatory effects in vitro and in animals, the study suggests ‘Ashwagandha’ as a potential therapeutic candidate for alleviating the long-term symptoms of COVID-19.
“After the trial’s success, ‘Ashwagandha’ will be a proven medicinal treatment to prevent infection and be recognised by the scientific community worldwide,” the Ministry said.
It added that despite successful vaccine development, COVID-19 continued to pose a substantial threat to health in the UK and globally. More than 15% of adults in the UK, where the clinical trials on ‘Ashwagandha’ were going to take place, and more than 10% globally had been infected with the Sars-Cov-2 virus.