The substance, called Coronil, was launched recently at an event attended by some Indian government ministers.
It first appeared in June last year, promoted by popular yoga guru Baba Ramdev, and described - without any basis - as a "cure" for Covid-19.
But marketing had to stop after an intervention by the Indian government, which said there was no data to show it worked as a treatment.
However, the government said it could continue to be sold as "an immunity booster".
"It has treated and cured people," Acharya Balkrishna, managing director of Patanjali told the BBC.
It referred us to scientific trials, the results of which it says have been published in several peer-reviewed journals.
It pointed specifically to a study from November 2020 in a journal published by the Swiss-based MDPI, which was based on a laboratory trial. ("Application of Humanized Zebrafish Model in the Suppression of SARS-CoV-2 Spike Protein Induced Pathology by Tri-Herbal Medicine Coronil via Cytokine Modulation") [1]
However, this study was conducted on fish, and it does not state there was evidence Coronil could cure coronavirus in humans.
A human trial was conducted between May and June last year, on 95 patients who had tested positive for coronavirus.
Of these, 45 received the treatment and 50 were part of a placebo group (who didn't receive anything).
The Patanjali company pointed out the results have appeared in a peer-reviewed journal called Science Direct in its April 2021 edition. ("Randomized placebo-controlled pilot clinical trial on the efficacy of ayurvedic treatment regime on COVID-19 positive patients")[2]
It said there were faster recovery rates among those who were given Coronil than those who were not.
However, this was a pilot study with a small sample size.
The WHO confirmed to the BBC that they have "not... certified the effectiveness of any traditional medicine for the treatment of Covid-19".
Dr Head, of Southampton University, says: "There is no clear evidence right now that this product is beneficial for treating or preventing Covid-19."
[1] Abstract
Zebrafish has been a reliable model system for studying human viral pathologies. SARS-CoV-2 viral infection has become a global chaos, affecting millions of people. There is an urgent need to contain the pandemic and develop reliable therapies. We report the use of a humanized zebrafish model, xeno-transplanted with human lung epithelial cells, A549, for studying the protective effects of a tri-herbal medicine Coronil. At human relevant doses of 12 and 58 µg/kg, Coronil inhibited SARS-CoV-2 spike protein, induced humanized zebrafish mortality, and rescued from behavioral fever. Morphological and cellular abnormalities along with granulocyte and macrophage accumulation in the swim bladder were restored to normal. Skin hemorrhage, renal cell degeneration, and necrosis were also significantly attenuated by Coronil treatment. Ultra-high-performance liquid chromatography (UHPLC) analysis identified ursolic acid, betulinic acid, withanone, withaferine A, withanoside IV–V, cordifolioside A, magnoflorine, rosmarinic acid, and palmatine as phyto-metabolites present in Coronil. In A549 cells, Coronil attenuated the IL-1β induced IL-6 and TNF-α cytokine secretions, and decreased TNF-α induced NF-κB/AP-1 transcriptional activity. Taken together, we show the disease modifying immunomodulatory properties of Coronil, at human equivalent doses, in rescuing the pathological features induced by the SARS-CoV-2 spike protein, suggesting its potential use in SARS-CoV-2 infectivity.
[2] Results
By day 3, 71.1 % and 50.0 % patients recovered in the treatment and placebo groups, respectively. Treatment group witnessed 100 % recovery by day 7, while it was 60.0 % in the placebo group. Average fold changes in serum levels of hs-CRP, IL-6 and TNF-α in treatment group were respectively, 12.4, 2.5 and 20 times lesser than those in the placebo group at day 7. There was 40 % absolute reduction in the risk of delayed recovery from infection in the treatment group.
Conclusions
Ayurvedic treatment can expedite virological clearance, help in faster recovery and concomitantly reduce the risk of viral dissemination. Reduced inflammation markers suggested less severity of SARS-CoV-2 infection in the treatment group. Moreover, there was no adverse effect observed to be associated with this treatment.
