Jahnavi Sarma
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Written By: Jahnavi Sarma | Updated : June 25, 2020 9:06 AM IST
Patanjali relaunched Coronil Kit at a press conference recently, calling it the first evidence-based Ayurvedic medicine for COVID-19.
Yesterday, Baba Ramdev's Patanjali launched Coronil, the drug that it claimed can cure COVID-19 bringing cheer and hope to the hearts of many. But just a few hours after the launch, the Union Ministry of Ayurveda, Unani, Siddha and Homeopathy (AYUSH) barred Patanjali Ayurved from advertising and publicising the drug. According to the Ministry, the facts of the claim and details of the stated scientific study are not known to it.
The Ministry has directed Patanjali to provide all details at the earliest including 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 has also put in a request with the concerned State Licensing Authority of Uttrakhand government to provide copies of license and product approval details of the said drugs.
This does not bode well for the company because this means that the sale of the drug is now on hold. According to Patanjalli, two of its drugs, 'Coronil', and 'Swashir Vati', was successful in treating 69 per cent COVID-19 positive patients at the end of three days of administration of the drug and 100 per cent after seven days of administration. The company also said that this was proven by clinical trials held in several cities including Delhi, Meerut and Ahmedabad.
The AYUSH Ministry meanwhile issued a statement that indicates that Patanjali went ahead with the publicity of the drug without keeping it in the loop. This was in clear violation of its order dated April 21, 2020 regarding research on COVID drugs. According to this order, it is mandatory for all organisations to appraise the ministry before going ahead with publicity for drugs meant for COVID-19. The statement also gave a reference to another order dated April 1, 2020, that specifically barred the publicity of what it terms AS 'false claims' of any COVID-19-related treatment in TV, print and electronic media. Doing so would lead to penal actions under National Disaster Management Authority guidelines. The ministry has now asked Patanjali to immediately furnish the details including results of trial besides the drug composition, testing protocol and sample size.
Though Patanjali Ayurved claimed to have discovered the cure for COVID-19, no medical authority was able to vouch for the claim. Meanwhile, according to reports, scientists associated with the trial said that the results of the trial are not published yet. According to experts who supervised the trial, 100 COVID-19 positive patients were recruited for the trial. Of them, 50 were given the medicine and five dropped out midway. The remaining 50 were given a placebo. According to them, 69 per cent of the 45 patients tested negative on the third day. Half of the patients who received a placebo recovered. Going by this, 31 patients on the medication tested negative and 25 patients on the placebo tested negative. There were no other details like the profiles of the patients, the severity of symptoms, age of participants or whether the patients were on any other medication prior to enrolment.
The Clinical Trial Registry, where all trials must be registered, reveal that participants of the trial were asymptomatic, mildly symptomatic, moderately symptomatic and between the ages of 15-80. Though the original aim of the study was to check the status of patients at day 3, day 7 and day 14, to determine whether they had improved immunological parameters due to the medicine, it is not known if this was done. The drugs used in this trial are Tablet Swasari Ras (500 mg), Tablet Pure Ashwagandha Extract (500 mg), Tablet Pure Giloy Extract (500 mg), Tablet Pure Tulsi Extract (500 mg) and Anu Taila (nasal drop).
