New Delhi: Patanjali’s Coronil, which company founder Baba Ramdev has touted as a cure for Covid-19, was tested only on young and healthy patients and not on high-risk ones such as the elderly or those with comorbidities, ThePrint has learnt.
Patanjali launched the drug Tuesday, but was asked to stop advertising it within hours by the Ayush ministry, which asked the company to send details of the drug, its composition and other related information.
Experts said Patanjali’s claims about the drug, which is supposed to be made of Ashwagandha, Giloy and Tulsi, could not be verified since the findings of the clinical trial were not submitted for peer review.
Patanjali said there has been a communication gap with the government, but claimed that it had received all the appropriate approvals. Acharya Bal Krishna, CEO of Patanjali Ayurveda, told ThePrint, “We have dispatched our response along with all necessary documents and earlier communications to the (Ayush) ministry. Hope it will be resolved soon.”
The initial brief of the Coronil study, uploaded to the government’s clinical trial registration portal, had mentioned that it would include moderately symptomatic patients as well. However, they were not included in the final study.
“The mean age of patients was 35-45 — mainly young, and they all were either asymptomatic or had mild symptoms,” Dr G. Devpura, principal investigator of Coronil’s clinical trials, told ThePrint.
“The criteria of clinical trials excluded patients with pre-existing diseases or co-morbid conditions,” he added. These include those with pre-existing diseases such as cardiovascular disease, diabetes or lung disease.
Those with comorbidities and the elderly are at the highest risk of dying from the infection. According to data with the Ministry of Health and Family Welfare, one in every two Covid-19 deaths in India has been of senior citizens, while 73 per cent of Covid-19 deaths in the country are of people with comorbidities.
Less than 100 patients tested in Coronil clinical trial
The National Institute of Medical Sciences (NIMS) in Jaipur conducted the clinical trials on behalf of the Haridwar-based FMCG major.
According to Dr Devpura, a professor at the institute’s Department of Medicine, the trials began on 23 May to check the impact of Coronil on Covid-19 patients. About 100 patients were enrolled for the study and they were divided into two groups of 50 each.
Around 45 patients were administered the ayurvedic drug while the remaining 50 were placed in the placebo group (no treatment).
“Five patients had refused to give consent, so they were removed from the study,” Devpura said. “On the third day of the treatment, 69 per cent of patients (around 30 patients) who were given ayurvedic drug had turned Covid negative. Around 50 per cent (around 25) in the placebo had turned negative at the same time.”
By the seventh day, he said everyone (i.e., 100 per cent) given the ayurvedic medicine were “cured” while 65 per cent of them (around 33), in the placebo arm had recovered.
Devpura, however, said the study is yet to be published for peer-review and “we might start another study to check the drug’s efficacy for moderate to severe cases,” he said while adding that “it is an interim study and final results are yet to be out”.
An instant controversy
Yoga guru Ramdev launched his ayurvedic medicine Coronil Tuesday, claiming it could treat Covid-19 within 14 days.
Coronil, according to Patanjali, is manufactured using active compounds of Ashwagandha, Giloy and Tulsi.
Soon after its launch, however, the Ministry of Ayush — the regulator for ayurvedic drugs in India — shot off a letter to the company asking it to furnish composition and research data while also directing it to not advertise it as a Covid-19 drug.
Following this, Patanjali said it has sent a 11-page reply to the ministry.
“There is a communication gap between the Ministry of Ayush and our firm. We have received the drug approval and everything has been done following the set protocols,” Acharya Bal Krishna, CEO of Patanjali Ayurveda told ThePrint over the phone.
Coronil claim not verifiable: Experts
From pointing out the low sample size to the absence of any published study, experts said it is difficult to comment on the efficacy of the drug based on the claims of the Haridwar-based Patanjali Ayurveda.
“The sample size seems to be too low to make a claim on efficacy as they have announced. Moreover, in the absence of any published study which is peer-reviewed, the data is just a claim that is not verifiable,” said Anant Bhan, adjunct professor and researcher in bioethics at Mangaluru’s Yenepoya University.
“It would be ideal to put the study protocol in public domain, provide more information on the medication used, and publish the study for an informed view to be taken,” he said while adding that “using a press conference to announce efficacy with lots of questions remaining unanswered, and inadequate information available in the public domain, seems to be poor science.”
Others have questioned the trial itself.
“The sketchy protocol listed on CTRI (Clinical Trials Registry- India) website does not specify how the patient cohort was randomised. It doesnt say what the placebo was either,” tweeted Dinesh Thakur, a public health expert. “With a patient cohort of this size, what statistical analysis was done with the primary outcome to support the claim which was made? Mind you, the claim being made is “cure” for COVID-19.”
— Dinesh S. Thakur (@d_s_thakur) June 24, 2020
According to Dr Girdhar R. Babu, head, life course epidemiology, Public Health Foundation of India, “The information is insufficient as this is not from a peer-reviewed publication. I am really surprised why the group did not choose to publish this in a scientific journal first.”