New Delhi: In an attempt to validate the efficacy of traditional medicines and collect scientific evidence, the Narendra Modi government is ready to conduct clinical trials on three ayurvedic herbs and one medicine, ThePrint learnt.
The Ministry of AYUSH will conduct trials along with the Council of Scientific & Industrial Research (CSIR), India’s largest body for conducting research and development, and Indian Council of Medical Research (ICMR), the apex health research body.
“The candidates chosen for trials are three popular ayurvedic herbs — ashwagandha, guduchi, mulethi and an ayurvedic anti-malaria medicine AYUSH-64. These drugs will be studied for their preventive properties against Covid-19 infections,” a senior ministry official told ThePrint.
Ayush-64 is a patented medicine developed by the Central Council for Research in Ayurvedic Sciences (CCRAS). After hydroxychloroquine, an anti-mlarial drug, showed efficacy in treating the coronavirus infection, the government plans to check Ayush-64 pill for the same.
“We will be finalising the four cites for the trials within this month. We are getting proposals from public and private hospitals in Mumbai, Delhi, Lucknow and others for starting the trials. However, we are awaiting the nod from ICMR for finalising the geography,” the official said.
The Ministry of AYUSH — which stands for Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa and Homoeopathy — has faced repeated criticism for propounding pseudoscientific medicine as alternative medicine.
How trials will be conducted
Clinical trials are a type of medical research conducted by following a defined protocol within stipulated period to find out the efficacy and safety of a treatment.
The objective of the AYUSH ministry’s planned trials is to study the preventive properties of the four selected candidates — three herbs and one medicine.
“These herbs and medicine will be administered to asymptomatic people who are quarantined or isolated, and frontline healthcare workers. Herbs will be given in the form of tablets made through their extracts,” said the official.
The trial will be held for 15 days in two categories — standalone, where a patient will only consume ayurvedic pills, and add on, where allopathic drugs will be combined with the ayurvedic pills.
The trials will be conducted according to the protocols designed by the interdisciplinary 17 member-AYUSH research and development task force, led by professor Bhushan Patwardhan, vice-chairman, University Grants Commission.
“The Ministry of AYUSH has also undertaken consultation with the Drug Controller General of India (of the) Central Drugs Standard Control Organisation, the primary body which approves clinical trials in India,” the official said.
Focus also on research projects
Replicating the same move for other drugs under homeopathy, unani and siddha, the government released a notification Tuesday, inviting scientists and researchers to undertake research projects and generate evidence.
“…it is also essential to have scientific evidence on use of any Ayurveda, Unani, Siddha or Homeopathy formulation on prevention/management of COVID 19… It is also necessary that the clinical data generated is scientifically valid and credible,” said the notification.
Clinical trials for alternative medicines too
In the wake of Covid-19 pandemic, there has been surge in proposals received by the Ministry of AYUSH on possible treatments, ministry said in the notification.
The disease, caused by the SARS CoV 2 coronavirus, currently has not known cure, treatment or vaccine.
“…It is also essential to have scientific evidence on use of any Ayurveda, Unani, Siddha or Homeopathy formulation on prevention or management of COVID 19. Therefore, it is felt necessary to make serious efforts for development of drugs based on any of the AYUSH systems recognised under Drugs and Cosmetics Act, 1940,” the notification stated.
It further appealed to researchers to generate evidence on Covid-19 using the ancient medicines. “…The Ministry of AYUSH notifies that scientists, researchers, clinicians of any of recognized systems of medicine can undertake research on COVID19 through Ayurveda, Siddha, Unani and Homeopathy systems including prophylactic measures, intervention during the quarantine, asymptomatic and symptomatic cases of COVID -19, public health research, survey, lab-based research etc. to generate evidence.”
The notification allowed researchers to conduct clinical trials for checking the efficacy of the treatment along the allopathic treatment. There was no provision till now allowing clinical trials of AYUSH drugs in modern settings along with allopathic drugs.
“Now, to begin a clinical trial, the ministry will issue a no-objection certificate which would allow researchers to conduct trials in super speciality hospitals and along with modern medicine.”