INDIA's Ayush ministry has collaborated with the UK's London School of Hygiene and Tropical Medicine (LSHTM) to conduct clinical trials of Ashwagandha to study the efficacy of the herb on Covid patients.
The All India Institute of Ayurveda (AIIA), under the Ayush ministry, and LSHTM recently signed a memorandum of understanding to conduct trials on 2,000 people in three UK cities-Leicester, Birmingham, and London (Southall and Wembley), a statement said.
Ashwagandha (Withania somnifera), commonly known as 'Indian winter cherry', is a traditional herb that boosts energy, reduces stress, and makes the immune system stronger.
The herb is an easily accessible, over-the-counter nutritional supplement in the UK and has a proven safety profile, the statement added.
This is the first time the ministry is collaborating with a foreign institution to investigate its efficacy on Covid-19 patients.
AIIA director Dr Tanuja Manoj Nesari, who is also a co-investigator in the project has said that the participants have been randomly selected.
Dr Rajgopalan, coordinator – International Projects is also participating in the project. Dr Sanjay Kinra of 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."
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 recognized GCP (Good Clinical Practices) guidelines.
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.
It has also been indicated for treating non-restorative sleep, a hallmark of chronic fatigue, for which the trials are currently ongoing, the statement added.
Many studies suggested Ashwagandha as a potential therapeutic candidate for alleviating the long-term symptoms of Covid-19, Dr Nesari said.
