The AYUSH Ministry has collaborated UK’s London School of Hygiene and Tropical Medicine (LSHTM) to conduct clinical trials on Ashwagandha for promoting recovery from COVID-19.
The ministry in a statement 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 to conduct clinical trials of Ashwagandha on 2,000 people in three UK cities such as Leicester, Birmingham and London (Southall and Wembley).
Ashwagandha (withania somnifera) is a traditional herb that boosts energy, reduces stress and makes the immune system stronger. Ashwagandha is commonly known as ‘Indian winter cherry’.
The statement further said, over-the-counter nutritional supplement in the UK it is easily accessible and has a proven safety profile. If the trial is successfully completed it can be a major breakthrough and can 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, it added.
According to AIIA Director Dr Tanuja Manoj Nesari, 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 of LSHTM is the principal investigator of the study.
Dr Nesari said in the statement, “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.”
In this process the participants will have to take the 500 mg tablets twice a day and a monthly follow up of a self-reported quality of life, mental and physical health symptoms, damage to activities of daily living, and supplement use and adverse events will be carried out.
Dr Nesari said, it took over 100 meetings spanning about 16 months through both diplomatic as well as regulatory channels for signing of the MoU. The study has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and is certified by WHO-GMP, she added.
As per the internationally recognized GCP (Good Clinical Practices) guidelines, the study is being conducted, she added. Recently, a number of randomized placebo-controlled trials of Ashwagandha 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.
However, according to the statement it has also been mentioned that it has also been showed for treating non-restorative sleep, a hallmark of chronic fatigue, for which the trials are going on currently. The study suggests Ashwagandha as a potential therapeutic candidate for alleviating the long-term symptoms of COVID-19 combined with considerable literature on its pharmacological and immunomodulatory effects in vitro and in animals, it added.
Over 15 per cent of adults in the UK, where the clinical trials on Ashwagandha are going to take place, and more than 10 per cent globally have been infected with the SARS-CoV-2 virus.
Ashwagandha will be a proven medicinal treatment to prevent infection after the trials are successful and are recognized by the scientific community worldwide. Despite successful vaccine development, COVID-19 continues to pose a substantial threat to health in the UK and globally.