‘Patanjali’s breakthrough needs vetting’
NEW DELHI: India’s traditional systems of medicine, including ayurveda, have several proven preventive and curative drugs and therapies, but Patanjali Ayurved Ltd’s claim of a breakthrough cure for the coronavirus disease needs vetting, experts said, despite the company claiming to have conducted a randomised placebo-controlled clinical trial.
The principal investigator running the clinical trial at a Jaipur medical college confirmed the findings but said they were preliminary and the study, ongoing. He also clarified that the study was conducted on patients who were asymptomatic or had mild symptoms, between the ages of 35 and 45, and that no people with co-morbidities (considered the most vulnerable to the disease) were part of the trial.
Interestingly, a spokesperson for Patanjali, SK Tijarawala said that the company never “claimed that it (the medicines) were a cure for coronavirus disease; all we said was that the medicines in our kit that Patanjali has been selling individually to boost immunity and provide relief to patients of respiratory illness has been effective in improving symptoms of Covid-19 patients”.
Patanjali submitted (preliminary) results of the clinical trial to the ministry of Ayush (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) only after the latter demanded ”facts of the claim and details of the stated scientific study”. That came after the company, promoted by yoga guru Baba Ramdev, went public with its discovery. He was later interviewed by several TV channels where he talked up the discovery. The scientific title of its clinical trial, according to documents submitted by the company is : Impact of Indian traditional Ayurvedic treatment regime for nCov-2 (Covid-19)
On Tuesday, the ministry also directed the company to stop advertising the product till the claim was verified.
The Ayush ministry is currently in the process of examining the documents.
“It’s a good thing that Baba Ramdev has given a new medicine to the country, but as per rules, it has to come to the Ayush ministry first. They even said that they have sent a report; we will look into it and permission will be given after seeing the report,” Ayush minister Shripad Naik told news agency ANI on Wednesday.
It wasn’t immediately clear how the company launched its product without a clearance from the ministry.
A senior official in the ministry of Ayush said, “We weren’t aware of it (the drug) until yesterday (Tuesday), and now that they have submitted the documents, our experts will be examining it before anything is said conclusively. There is a protocol for conducting clinical trials , so we will examine what kind of approvals they have, and what type of trial was conducted with the primary and secondary objective.”
According to the trial data submitted by the company, in a double blind single centre randomised study at a hospital in Jaipur, the National Institute of Medical Sciences, the drug was tested on 120 patients. The primary outcome was the virological clearance in a RT-PCR test at “baseline”, after three days, and after seven days.
The secondary outcome was reduction in Serum C reactive protein (CRP) and IL-6 levels. High CRP and IL-6 levels are an indicator of inflammation.
According to the findings of the trail, there was a 69% recovery on Day 3 in the treatment group, and 100% recovery at Day 7, which was 35% better recovery than the placebo group. The documents said that “Serum CRP levels are lesser in treatment group” and that there was a “remarkable decrease in IL-6 levels”.
According to Dr Ganpat Devpura, a professor of medicine at NIMS and the principal investigator of the trial, by design, excluded people with co-morbidities and the age of patients studied was 35-45 years . He also added that the patients were either asymptomatic or mildly symptomatic because those were the kind of patients available for the trial at the hospital.
Clinical trials usually have wider samples. Several voices have raised concerns about the trial design since Tuesday when Patanjali made the results public.
“The #PatanjaliAyurved trial enrolled 120 Covid+mildly ill patients & looked at viral clearance and decrease in IL-6 levels as endpoints. IL-6—the indicator of severe inflammation & cytokine storm—is unlikely to be elevated early in these patients. How would the drug impact it?” tweeted SP Kalantri, who identifies himself as a physician, teacher and researcher among other things.