Clinical trials will be conducted on 2,000 people in three U.K. cities, says Ministry of Ayush
A Ministry release said that the All India Institute of Ayurveda (AIIA), an autonomous body under the Ministry of Ayush, and the LSHTM recently signed a Memorandum of Understanding to conduct clinical trials of ‘Ashwagandha’ on 2,000 people in three U.K. cities — Leicester, Birmingham and London (Southall and Wembley).
‘Indian winter cherry’
‘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 U.K. 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.
It added that the successful completion of the trial could 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,’’ the Ministry said.
Randomly selected
According to AIIA director Tanuja Manoj Nesari, who is also a co-investigator in the project along with Rajgopalan, coordinator–International Projects, the participants have been randomly selected. Sanjay Kinra of the 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 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 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.
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 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 noted.
It added that despite successful vaccine development, COVID-19 continued to pose a substantial threat to health in the U.K. and globally. More than 15% of adults in the U.K., where the clinical trials on ‘Ashwagandha’ was going to take place, and more than 10% globally had been infected with the Sars-Cov-2 virus.
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