By – Vasudevan Mukunth
Patanjali Ayurved, the FMCG company owned by yoga guru Baba Ramdev that has made a windfall selling food and consumer goods rooted in supposed Ayurvedic precepts and by capitalising on protectionist sentiments, claimed on Tuesday that it had developed an Ayurvedic product that could ‘cure’ COVID-19.
At a launch event earlier this week, Ramdev said their Patanjali Research Institute had produced an “evidence-based ayurvedic cure” for COVID-19, the disease caused by the novel coronavirus that has thus far claimed 4.4 lakh lives around the world. The company’s chairman Acharya Balkrishna said their ‘corona kit’ includes two medicines – named Coronil and Swasari – that will be available in company storefronts for Rs 545 in a month.
However, neither Ramdev nor any company representative presented any evidence to support their claims – not even results from a well-design randomised controlled clinical trial, the gold standard of modern medical tests. They did present some data from “randomised clinical trials” they claimed to have conducted but which failed to persuade many experts of the legitimacy of their claims.
Curiously enough, the Ministry of AYUSH pulled up Patanjali Ayurved shortly after, asking it to stop advertising Coronil and holding its sale of the drug until the ministry could verify the claims. This is curious because the ministry itself has been routinely upbraided by the scientific community for failing to regulate phytotherapeutic products in the market and to ensure they’re safe and efficacious vis-à-vis their medicinal abilities.
Patanjali’s event as well as the ‘kit’ contravene a set of rules the ministry notified in December 2018. They prohibit “the manufacturer, or his agent, of Ayurvedic, Siddha or Unani drugs” from participating “in the publication of any advertisement relating to any drug for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition.”
According to information presented at the launch, researchers at the NIMS University in Jaipur, with which Patanjali Ayurved conducted the study, recruited 100 COVID-19 patients for their trial; 95 eventually participated. At the end of the trial, according to the company, “69% virus-positive patients recovered within three days and 100% patients recovered within seven days.” According to The Hindu, 45 of the 95 were in the treatment group and 50 in the placebo group.
However, these details don’t suffice to properly interpret the results of a clinical trial. Other important details include the duration of the trial, biological sex of each participant, the clinical reports of each participant (including comorbidities if any), safety studies, specific description of the trial’s settings, the tests that were conducted to ascertain the clinical status of each participant (plus their error rates), the statistical significance of the results, the side effects reported and the post-therapy follow-up period and changes in clinical status (if any) in this phase.
This information was left out of the announcement but it may have been included in the paper itself. However, experts expressed concerns that they couldn’t find the paper published in any journal. In its press note, the Ministry of AYUSH said it had requested these and some other details.
The trial’s registration on the Clinical Trials Registry of India (CTRI) is more detailed. It doesn’t include the words ‘Coronil’ or ‘Swasari’ but acknowledges Patanjali as its source of funds. But it’s still not helpful.
For example, it states that the study’s duration was two months. The compounds administered to patients and their dosages were as follows: pure ashwagandha, 500 mg; pure giloy extract, 1,000 mg; pure tulsi extract, 500 mg; anu taila, four drops; and swasari ras, 2 g. The researchers then test the patients with RT-PCR at baseline (start of the trial), after seven days and after 14 days, and follow up at the 14-day and 30-day marks.
However, there are numerous inconsistencies. The date of first enrolment was May 29, which means it’s been less than a month since the trial commenced. So as such Patanjali Ayurved has come out with a product before the clinical trials, stipulated to be two months long, concluded. The ‘recruitment status’ is also set to ‘open’, which means patients are still eligible to participate in the trial.
More: only one site of study is listed – NIMS’s department of medicine – and with 95 participants, contrary to claims during the launch that the trial had been conducted in Delhi, Ahmedabad and other cities, and with 280 participants. It is possible that there has been more than one clinical trial. However, a search on CTRI for interventional clinical trials with ‘NIMS’ or ‘Patanjali’ as keywords didn’t yield any other results (caveat: the CTRI search feature is known to be imperfect).
The study’s secondary outcomes include ‘conversion from symptomatic to asymptomatic patient’, ‘reduction in C-reactive protein’ and ‘ESR and IL-6 improvement in haematological parameters’. These details, together with others specified above, aren’t available. The trial’s phase and publication details are both listed as ‘nil’.
A detailed press release accompanying the launch of Coronil and Swasari stated: “Upon entrance, Corona virus disrupts the functional unit of respiratory system named as Alveoli and further interferes with the physiological aspects of human body. Virus infection triggers the cytokine storm while undergoing the replication to produce its multiple copies. Above mentioned Ayurvedic medicines obstruct the replication process and mitigate its infection by increasing the body’s fighter cells thereby controlling the current outbreak.”
This is a dressed-up version of the generic ‘immunity boosting’ claim, although it doesn’t explain which ‘fighters’ will be boosted. A cytokine storm, for example, is the result of the body aggressively producing too many infection-fighting proteins called cytokines that subsequently damage the body’s tissue itself.
In sum, the study considered only 95 patients instead of hundreds, if not thousands, and the compounds administered – ashwagandha, giloy, etc. – enjoy a common reputation as ‘immunity boosters’ (another term that has been widely misunderstood during the pandemic), and don’t represent any medical innovation. So Patanjali Ayurved’s products only warrant more skepticism.
Emails to Ganpat Devpura, a principal investigator of the study, and Abhishek Sharma, the contact person listed, went unanswered.
This isn’t the first time Patanjali has taken liberties with its claims to scientific vigour, especially by announcing results via press releases instead of published papers. In 2016, a newspaper advertisement trumpeted that Patanjali’s ‘Ayurvedic Mission’ was based on “intense research” over “25 years”, with “tests on over 1 crore people”. Pushpa M. Bhargava, the late founder-director of the Centre for Cellular and Molecular Biology, Hyderabad, subsequently wrote for The Wire:
If “intense” research has been carried out for 25 years, it must have been done by research scientists in an institution and the results put in public domain. … No such publication is mentioned in the ad or is known to exist. … Who were these scientists and what were their qualifications? What was the name and location of the institute? What was the research methodology used? Even if you have all the test results of one individual recorded on one page, for one crore individuals you would need at least one crore pages of recorded data; with 300 pages per volume, the number of volumes of data would be well over thirty thousand. Where are they? Will Ramdev answer these questions?
In a more recent incident, Balkrishna, the chairman of Patanjali Ayurved, had said the company would “monetise the findings” of a study published in February. Its accompanying paper claimed to prove that ashwagandha seeds treat psoriasis, a skin disorder whose causes and cures remain unknown. However, the study had been conducted in mice and the paper was written in Sanskrit, rendering it nearly impossible for independent scientists to verify the study’s claims.
On the other hand, in April this year, the Ministry of AYUSH constituted an interdisciplinary task-force that announced an extramural research scheme: to test the efficacy of a small group of compounds, including ashwagandha and AYUSH-64, as prophylactics against COVID-19. The task-force’s secretary had told The Wire Science in May: “Of the 2,300 projects received, only single-digit proposals are likely to be funded.”