Ayush-64 is an Ayurvedic formulation, developed by the Central Council for Research in Ayurvedic Sciences (CCRAS), the apex body for research in Ayurveda under the Ministry of Ayush. Originally developed in 1980 for the management of Malaria, this drug has now been repurposed for COVID-19 as its ingredients showed notable antiviral, immune-modulator, and antipyretic properties. Its ingredients are:
|Alstonia scholaris R. Br. Aqueous extract of (Saptaparna)||Bark-1 part|
|Picrorhiza Kurroa Royle Aqueous extract of (Kutki)||Rhizome-1 part|
|Swertia chirata Buch-Ham. Aqueous extract of (Chirata)||Whole plant-1 part|
|Caesalphinia crista, Linn. Fine powder of seed (Kuberaksha)||Pulp-2 parts|
The crucial question, of course, is does AYUSH-64 work?
An open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India with 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone.
The outcome measures were:
- the proportion of participants who attained clinical recovery on days 7, 15, 23, and 30,
- the proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point,
- change in pro-inflammatory markers,
- metabolic functions,
- HRCT chest (CO-RADS category),
- the incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE).
Out of 80 participants, 74 (37 in each group) contributed to the final analysis. A significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. The mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG.
The authors concluded that AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.
I do object to these conclusions for several reasons:
- The study cannot possibly determine the safety of AYUSH-64.
- Even for assessing its efficacy, it was too small.
- The trial design followed the often-discussed A+B vs B concept and is thus prone to generate false-positive results.
I believe that it is highly irresponsible, during a medical crisis like ours, to conduct studies that can only produce unreliable findings. If there is a real possibility that a therapy might work, we do need to test it, but we should take great care that the test is rigorous enough to generate reliable results. This, I think, is all the more true, if – like in the present case – the study was done with governmental support.
Meanwhile, in a similar study AYUSH-64 did not show statistically significant effect:
https://thewire.in/health/covid-19-small-preliminary-study-doesnt-find-proof-of-ayush-64s-efficacy. But that did not stop the BJP government from promoting AYUSH-64 as a treatment for Omicron:
The study states “There was no significant difference in HRCT CO-RADS category score between the groups at baseline”
But there again 35.1% of the treatment group has CO RADS 1 compared to 21.6% in the control group.
Strikes me that a group who had better lung condition to begin with were suffering less with Covid.
In addition, the clinical symptoms end point is surely subject to quite subjective assessments.
And we have another A+B compared to B study.
It makes sense as a pilot study – they can do a better and more expensive study later.
But it seems strange they wouldn’t use a placebo control. They gave the Ayush-64 in the form of tablets, so they could give the control group placebo tablets.
Especially the first outcome measure, clinical recovery as defined by the absence of symptoms, is susceptible to placebo effects. And that was where the difference in outcomes was especially striking.
There is no shortage of poorly designed studies on Ayurveda coming out of that part of the world, most of them courtesy of Ministry of Ayush. They fund a network of alt-med research institutes and colleges: https://en.wikipedia.org/wiki/Ministry_of_Ayush that produce these questionable studies.
You asked for an RCT, here is one: https://pubmed.ncbi.nlm.nih.gov/34908795/.
Here is one on that came out in May 2020: https://pubmed.ncbi.nlm.nih.gov/33446377/ that is not without controversy: https://science.thewire.in/health/covid-19-ministry-of-ayush-untested-medicines-risk-compensation-threaten-india-pandemic-response/
Early on during the pandemic, Ministry of Ayush started promoting alt-med remedies based on these shoddy studies: https://theprint.in/health/early-data-from-alternative-medicine-trials-shows-promising-results-against-covid-ayush-secy/441563/