The COVID-19 pandemic has given a big boost to the Ayurvedic and other alternative therapeutics industry. Despite limited evidence, several ayurvedic products are being endorsed by many including the health minister and the Prime Minister of india.
Chyawanprash is one such ayurvedic formulation made of super-concentrated blend of herbs and sugar. It is a popular household product sold by most Ayuvedic firms like Patanjali, Dabur, Emami and others. In the pandemic, as per a report, products like Chaywanprash have seen an 85% increase in demand.
Dabur -one of the biggest Ayurvedic companies in India also sells Chaywanprash. They recently published an advertisement in several newspapers to claim that Chyawanprash could protect against COVID-19. Dabur made this statement with a claim that it had conducted a clinical trial research study of the formula that supported the statement. Similarly, on their website, Dabur claims that consumption of their Chyawanprash reduced the risk of COVID-19 by up to 12 times in their study. No research of the said clinical study was shared on the website.
This drew flak from several people including the Advertising Standards Council of India which suo moto registered a complaint against the advertisement. We looked at Dabur’s claim and the general efficacy of Chyawanprash in preventing COVID-19 and found no scientific evidence in the form of published peer reviewed articles. In a previous story, Alt News Science earlier found no scientific basis for using Ashwagandha in treating COVID-19 as prescribed by the AYUSH Ministry.
Alerting @ascionline ! How reliable and valid is the study @DaburIndia is quoting? Please find out and pass your verdict. @rameshnarayan @skswamy @beastoftraal @calamur @bhatnaturally Two spoons vs Two shots of vaccine? pic.twitter.com/UgKAc2MZxn
— Ambi Parameswaran (@ambimgp) March 26, 2021
- Dabur claims that regular consumption of their Chyawanprash reduced the risk of COVID-19 by up to 12 times.
- Chyawanprash consumption can prevent COVID-19.
In India, any clinical or human trials have to be registered with the ICMR’s Clinical Trials Registry – India (CTRI) before the trial begins, including AYUSH trials. Despite some shortcomings, CTRI entries help in ensuring better transparency, accountability and accessibility of trial-related data.
We did a keyword search for ‘Chyawanprash’ and ‘Chyavanprash’ and found 10 clinical studies registered with CTRI. All these studies are trying to test if Chyawanprash consumption can prevent COVID-19.
|No.||Registration Date||CTRI Entry||Primary Sponsor||Study Type||Sample Size||Phase as per CTRI||Publication|
|1||27 April 20||CTRI/2020/05/025484||CCRAS NIIMH||RCT Open Label||5000||2/3||None|
|2||2 May 20||CTRI/2020/05/024981||Dabur India||RCT Open Label||696||NA||None|
|3||20 May 20||CTRI/2020/05/025275||CCRAS Ind Gov||RCT Open Label||200||3||Preprint|
|4||28 May 20||CTRI/2020/05/025425||CCRAS Ind Gov||Single Arm||50||3/4||None|
|5||31 May 20||CTRI/2020/05/025493||AYUSH, Telangana||Single Arm||1500||2/3||None|
|6||3 June 20||CTRI/2020/06/025561||AYUSH, Telangana||RCT Open Label||500||2/3||None|
|7||19 Sept 20||CTRI/2020/09/027914||Dabur India||RCT Open Label||72||2/3||None|
|8||22 Sept 20||CTRI/2020/09/027974||CCRAS Ind Gov||RCT Open Label||200||2||None|
|9||14 Jan 21||CTRI/2021/01/030454||Emami Zandu||RCT Open Label||300||2/3||None|
|10||24 Jan 21||CTRI/2021/01/030733||Emami Zandu||RCT Open Label||60||2/3||None|
Out of these 10 studies, two were from Dabur India (last searched 3rd of April 2021). As per their CTRI entry, one of them had 696 participants and was conducted across 5 different centres. These details match with the study which was cited by Dabur in its advertisement and website.
We did a keyword search for ‘Dabur Chyawanprash Clinical study on Covid-19’ on Google Scholar and PubMed database of scientific publications and found no results. Similarly, there were no preprints of the study on both BioRxiv and MedRxiv preprint servers. This means that there is no research paper published by Dabur to back their claim.
The results listed on their website are suspicious. The website claims that out of 351 participants who consumed Chyawanprash, 2.38% tested positive for COVID-19. 2.38% of 351 is 8.3538. The number of participants cannot be decimal, It has to be a whole number. Similarly in the control group, 28.57% of 345 tested positive for COVID-19. This comes out to be 98.5665 which is again a fraction and not a whole number.
If we round up the decimal, 99 participants tested positive for COVID-19 in the control group as compared to just eight in the Chyawanprash group. This result is unbelievably high. One way to look at this result is that if a vaccine had these numbers, it would be 92% efficacious! Higher than both the Covaxin (81%) and CovidShield (76%) vaccines used in India right now.
Extraordinary claims require extraordinary evidence. In Dabur’s case, there is no evidence at all. Dabur has not published any papers on either of the clinical trials they did on Chyawanprash. Hence the claim on their website and newspaper advertisement is misleading.
An inconclusive preprint study with Chyawanprash
Of all the 10 clinical studies listed above, only one of them has been published. That too was published as a preprint and not as a peer-reviewed research paper. This study was funded by the Central Council of Research in Ayurveda Sciences (CCRAS), Ministry of AYUSH. They tried to test if Dabur Chyawanprash could prevent COVID-19 in a sample of just 193 participants. The conclusion as per their preprint is “Chyawanprash was well tolerated by all the participants in the intervention group but to prove its adaptogenic effect and efficacy as an add-on to the standard care in preventing the occurrence of COVID-19, clinical trial for longer duration with larger sample size is needed.”
Further, the results of this preprint also suggested that those who consumed Chyawanprash had a significantly higher level of IgG -a long term inflammatory marker, usually due to longer lasting but subtle food sensitivities, than those without Chyawanprash. This result also means that the immune response due to Chyawanprash may be unfavourable for the body.
Analysis of other Chyawanprash clinical studies paints a bleak picture. Consider this study funded by CCRAS where 49 participants were given Chyawanprash for 30 days and there was no control group. After the end of a month, two of the 49 participants ended up testing positive for COVID-19 yet the CTRI entry concludes, “The outcome of this pilot study is encouraging in context to a possible safe prophylactic remedy for COVID-19’’. This study has no scientific publication of the results either as a paper or a preprint yet.
Similarly, other Chyawanprash trials are poorly designed too. While most of them have a control group, none of them is blinded. To ensure that the trial is not affected by bias, blinding is carried out where participants and clinicians are not informed whether they are getting the drug or the control. When blinding is not carried out, the researcher and the study participant may under-report their symptoms with a favourable view of Chyawanprash.
There are some registered trials with larger sample sizes such as NIIMH-CCRAS, a Ministry of AYUSH funded study which has 5000 participants. This trial can give acceptable results if it is conducted properly. NIIMH-CCRAS is also funding a study of Chyawanprash as a COVID-19 preventive agent in 1500 police personnel in Telangana. But as per their CTRI data, both the trials should have ended by now but there is no public record of their results.
As per their CTRI entries, several of the 10 trials should have completed their recruitment long back and yet there are no publications from most of those trials. One reason to explain this could be the file-drawer effect or publication bias. This happens when researchers register their trial, complete the trial but don’t publish their results because it is negative or inconclusive. Not publishing negative results is not just the breach of the trust of the study participants but also of citizens who funded many of these trials via the AYUSH ministry. CTRI registration was made mandatory to track such trials that don’t end up sharing their results.
There is just a single published preprint, with substandard methods and inconclusive results that was found to use Chyawanprash to prevent COVID-19. That study was inconclusive and could not establish Chyawanprash’s efficacy. The other nine trials registered in CTRI are yet to be published. AYUSH ministry’s claim that Chyawanrprash can help in post-COVID-19 recovery is sans any evidence.
Dabur has released no research paper to support their claim and the summary on their website is highly dubious.
Therefore any claim of Chyawanprash’s success in preventing Covid-19 is misleading and unreliable.