By Economic Times – No nod to Patanjali products for Covid treatment: AYUSH ministry New Delhi: A day after yoga guru Baba Ramdev’s Patanjali Ayurved announced the launch of its Covid-19 medicines, the principal investigator conducting the clinical trials for the products said the trials were incomplete, while Uttarakhand’s AYUSH ministry said it had not approved these products for the treatment of Covid-19.
“It is an interim report. So, calling it a cure is simply wrong. The sample size is very small. We have tried this intervention on 100 people and the trials are still not complete,” said Dr Ganpat Devpura, professor of medicine at the National Institute of Medical Sciences (NIMS) in Jaipur, where the trials were conducted. “The total sample size of the trial was 120. We still have to enrol 20 more people. Though the research is on the positive side, it is certainly not a cure,” he said.
“There is a team of qualified researchers who have worked on the process. So far we have made a disclosure of clinical trial results on mild and medium Covid positive patients. We are awaiting further clearances from the AYUSH ministry to take this further,” he added.
Patanjali’s founder Baba Ramdev had told ET on Tuesday that the medicines would be in drug stores and available online within a week. “We have invested in this and are confident about the results. The medicines have no side effects,” he said.
India’s drug regulatory authority Central Drug Standard Control Organisation (CDSCO) says traditional medicines which include Ayurveda medicines don’t fall in its domain. “We have not given any approval. Also, it is not our domain. The state licensing authority of Uttarakhand must have given its clearance,” said a senior official.
But the Uttarakhand AYUSH ministry said its approval letter did not mention coronavirus and it had only approved immunity boosting and fever medication. It said a notice had been issued to the ayurveda company.
An official with the ministry of AYUSH , the parent ministry for alternate systems of medicine, too said the ministry had not given permission for trials. The ministry has asked Patanjali to submit details of the sample size and study results data. “The ministry will have the study documents verified for validation of the data of the research outcome,” it said in a letter written to Patanjali, which ET has seen.
The company had on Tuesday expressed satisfaction with the results of the trial. Jaideep Arya, central chief coordinator at Patanjali Yogpeeth tweeted that the results were amazing — within three days 69% of the patients were cured from ‘positive infection’ and all patients were cured within 7 days.
Dr Abhishek Sharma, the coordinating investigator of the clinical trials at NIMS Jaipur, said the interventions were tested on asymptomatic and mildly symptomatic patients. “The trials were conducted on 15-80 age groups and the mean age was 33-34 years. The trials showed 69% recovery in the active group and 50% recovery in placebo,” he said.
Dr Sharma said results of the study were yet to be submitted to the Clinical Trial Registry of India (CTRI). “We will submit the details after we are through with the trials. This is going to take time,” he said.
According to the CTRI, the trial was registered on May 20 and the date of first enrolment is May 29. The study is interventional randomized parallel group placebo controlled, single centric trial in which the impact of Indian traditional ayurvedic treatment regime for nCoV-2 (Covid-19) was assessed.
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