‘All parameters met’: Patanjali claims Coronil clinical trial details furnished to Centre
A senior functionary associated with yoga guru Ramdev has claimed that the Central government has been provided with all the necessary details of clinical trials of Coronil- the product launched on Tuesday by Patanjali Ayurved ltd, founded by the yoga guru, as alleged treatment for coronavirus patients.
Ramdev’s associate Acharya Balakrishna tweeted a clarification to claim that 100% parameters laid down for controlled trial of this Ayurvedic product have been followed by the company after Patanjali Ayurved Ltd was asked by the AYUSH ministry of government of India to suspend advertisements promoting use of Coronil, launched on Tuesday, as an effective treatment for the deadly Covid-19 infection.
“This government encourages Ayurveda and works for its glory, the communication gap has been filled and the Ayush ministry has been given all the information regarding the 100% fulfillment of all the standard parameters of Randomized Placebo Controlled Clinical Trials (of Coronil),” Balakrishna tweeted.
His tweet followed AYUSH ministry asking Patanjali Ayurveda Limited to provide the composition and other details of the alleged Ayurvedic medicine to treat Coved-19 and putting on hold the product’s advertisements until an examination of its claim.
Patanjali Ayurveda has launched the ‘Coronil and Swasari’ products with the claim that it has successfully cured scores of under-trial Covid-19 patients with 100% results except for those on life support systems.
The ministry asked Patanjali to submit details of the sample size, sites and hospitals where the research study was conducted and also for the Institutional Ethics Committee clearance.
“Patanjali Ayurved Ltd has been asked to provide at the earliest details of the name and composition of the medicines being claimed for COVID treatment; site(s)/hospital(s), where the research study was conducted for COVID-19; protocol, sample size, Institutional Ethics Committee clearance, CTRI registration and results data of the study (ies) and stop advertising/publicizing such claims till the issue is duly examined,” the ministry said in its statement.
Ramdev had claimed that the first clinical controlled study was conducted on 280 patients in Delhi and Ahmedabad among many other cities.
In a guideline issued in April this year, the AYUSH ministry had laid down several conditions for organizations researching remedies of Covid-19 infection through use of traditional medicine.
According to the guidelines, AYUSH registered practitioner/expert should be part of the study/research team at each site and the research should be conducted in line with AYUSH guidelines for clinical research or ICMR guidelines. It must also comply with relevant regulations for bio-medical and health research and good clinical practice guidelines along with national ethical guidelines. Among other conditions, the proposal/research should be approved by their scientific advisory bodies and institutional ethics committee.