Yoga guru Ramdev's Patanjali Ayurved launching the Corona kit | Twitter
Yoga guru Ramdev's Patanjali Ayurved launching its Corona kit | Twitter
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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”.


Also read: ‘Covid drug’ favipiravir to be available at Rs 103/tablet by month-end


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.”

 

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.”


Also read: Lockdown saw fall in cancer care, child delivery claims under Ayushman Bharat: Govt report


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13 Comments Share Your Views

13 COMMENTS

  1. so government such as the one in Maharashtra can distribute HCQ and Arsenic Album 30 without any trial, peer review, randomised tests or medical documentation but you can’t do that for coronil because if you do this whole liberalism concept would face sn existential crisis.

    Here a government body has blocked the medicine and clearly issued advisory later not to sell as cure and some folks on this comments section go about how they are hand in gloves with the central government.. oh, tell me more

    • They are all wrong. Since when did inappropriate HCQ and fake medicine homeopathy become liberalism?
      Pseudoscience is pseudoscience, neither liberal nor conservative. It is just stupid.
      Maharashtra govt is incompetent, as is AYUSH.

  2. The print.. anti nationlals.. all major medicine on earth are derivative of plant which is our foundation of ayurveda. Everything indian and hindu is bad for you. Is not it? People are watching you.

    • All major medicines are not plant derivatives. Some are.
      Plant based does not mean Ayurveda. All old medicine from every country had plant sources because what else was there before science?
      Bad science and lying about cures should not mean nationalism.
      It sounds like for you as long as it is Hindu, we should forget about science and not check for truth. If anyone questions, he is anti-hindu for you. So for you, to be Hindu Nationalist means one has to be stupid.

  3. Dr. Faucis endorsement in itself counts more than reviewed publication.
    If you now go through the statistics of Coronil study, you will lose all your respect that you backed the claim.

    • Not sure what you meant.
      Dr. Fauci is a real scientist. He would never “endorse” fake studies like these.
      Where is India’s Dr. Fauci? People like Yesso Naik didn’t even study science and have no intelligence.
      We should be angry that stupid and badly educated people are put in charge by this government.

  4. No body asked single question on side effect of glenmark medicine. 35 percent of their share price increased. Logically medicine is for corona so first trial should be on corona patient not with comorbidities one. Are we expecting corona medicine to cure for comorbidities too. Than 2nd trial should be with comorbidties.
    Even if its improving 5 percent of body immunity in just 600 rs its worth. In comparison to 3500 rs with side effect.

    • Lol ..your ignorance is showing ..it’s people with co-morbid(pre-existing conditions) that the the corona becomes severe in and possibly leading to death. Those who are younger and have no co-morbid conditions(like the ones Ramdev’s company tested) , the bodies own immune system can usually just cure it on their own without needing to take any medicine. Which is why Patanjali very cunningly only tested on those young people with no pre-existing conditions cause they knew just like everybody else that their own immune system would take care of the disease and Patanjali could claim credit for it. It’s ignorant people like you that Ramdev and Patanjali is targeting so please do educate yourselves. Sadly its people like Ramdev and Patanjali that’s destroying the credibility of Ayurveda so that they can mint their billions. Ayurveda does work but these people are just frauds and fake marketers piggybacking on people’s trust and ignorance. I doubt Ramdev knows anything about Ayurveda.

  5. These Patanjali people are cunning.

    According to China CDC, chances of not being cured of COVID-19 is as follows.

    ages 10-19: 0.2%
    ages 20-29: 0.2%
    ages 30-39: 0.2%
    ages 40-49: 0.4%
    ages 50-59: 1.3%
    ages 60-69: 3.6%
    ages 70-79: 8%
    80 and over: 14.8%

    This does not even eliminate young people with pre-existing conditions like Patanjali eliminated.
    Most cases are very mild. To encounter even 1 not cured case (fatal), they would need more than 300 people in the study. They tested 45 and closed the study in a hurry.

    These quack medicines don’t cure anything. AYUSH licensed it as fever and cough medicine and these frauds sold it as COVID-19 cure. Even fever and cough claim is also quite doubtful. These scammers say they have medicine for homosexuality and for conceiving male child. They can get away with anything because PM and ruling party support them. No standards for herbals. It is a racket.

  6. One should equally wonder about the efficacy of Remdesivir, which was also announced in a press conference and not through a peer reviewed publication, and endorsed by Dr.Fauci. It reduced hospitalization time from 14 days to 11 days!. Not a magic bullet and yet we are into producing Remedesivir. Why the double standards, Let the Coronil be tested widely. Pharma power is too big to resist but Ayurveda can be played with.

    • Because remdesivir trials were conducted by the NIADH (a govt. agency) and not by Gilead alone. Also there results were published within a week of declaration as medical research journals have a long process of peer review. Also see the size of remdesivir trials, more than 1000 cases, this doesn’t even touch 100. I’m not against ayurved, I am against not following the protocols set by ICMR and DGCI for a clinical trial. Also remdesivir was in phase-3 trial as it had been tested during Ebola before, therefore clearing phase-1 and 2 at that time. Coronil is a new drug, it needs to clean phase 1-3 before being approved for emergency use. Hope you realise it’s not doubly standard but lack of standards followed by patanjali. If after proper trials and published results showing it’s superiority over other drugs, it’s still not approved then it’s an issue of double standard

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