Chyawanprash for the prevention of COVID-19 infection among healthcare workers: A Randomized Controlled Trial

Abstract

Background

Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are at high risk of exposure, the standard of care is personal protection from getting infected. Whether Ayurvedic rasayana drug like Chyawanprash can prevent symptomatic infection in frontline health care workers is unknown.

Objective

To evaluate the effect of the combination of Chyawanprash and Standard Preventive Regimen compared to the use of Standard Preventive Regimen alone on the proportion of RT-PCR confirmed COVID-19 infections among frontline healthcare workers (HCWs).

Methods

An open-label randomized controlled trial was conducted in the HCWs between 25 to 60 years age currently working in an environment with chance of direct exposure to COVID-19 cases. The interventions to be compared in this trial were Standard Preventive Regimen as per institutional guidelines and based on their roles (Group I) and Ayurvedic Intervention viz., Chyawanprash 12 g twice for 30 days from day of randomization plus Standard Preventive Regimen (Group II). The incidence of RT PCR confirmed COVID-19 cases in both groups, was the primary outcome measure. Evaluation of the safety of the study drug (by any statistically significant change in various biochemical and hematological parameters and occurrence of any adverse drug reactions); incidence of any other infective diseases (bacterial /viral/ fungal / etc.) like upper respiratory tract illness during the study period and any change in the immunoglobulins like IgG, IgM and IgE and inflammatory markers like TNF alpha, IL-6 and IL-10 were the secondary outcome measures.

Results

Out of 193 participants who completed the study, no participant in both groups was COVID-19 positive at the end of one month. In post intervention follow-up, 4 subjects in Group I and 2 subjects in Group II were COVID-19 positive. No adverse drug reaction or any serious adverse event was reported during the study. No clinically significant change in the safety parameters was observed before and after the study. Statistically significant rise in Serum IgG level was seen in Group II but other inflammatory and immune markers did not show statistically significant difference.

Conclusion

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.

Trial registration

Clinical Trials Registry of India vide CTRI/2020/05/025275 dated 20/05/2020

Date of IEC approval

19.5.2020

SciScore for 10.1101/2021.02.17.21251899: (What is this?)

Please note, not all rigor criteria are appropriate for all manuscripts.

Table 1: Rigor

Institutional Review Board Statement	IRB: Ethics committee approvals were obtained before study initiation. Consent: Study Participants All the Health care workers of either sex functional at the said study setting during the study period were screened for inclusion and exclusion criteria after getting informed written consent.
Randomization	Methods Study Design A randomized controlled trial was conducted between May 2020 to September 2020 among 199 HCWs functional at the COVID-19 Isolation Ward in Choudhary Brahmaprakash Ayurveda Charak Sansthan’s Hospital, Khera Dabur, New Delhi, India.
Blinding	not detected.
Power Analysis	Statistical Analysis Sample size calculation On the basis of assuming incidence of COVID – 19 in only 40% patients in Group I (Standard of care) as compared to 20% in Group II (Chyawanprash as add on to the standard of care) with 95% Confidence Level (α = 0.05), 80% power and expecting a dropout rate of 20%, the number of patients to be enrolled in the study was calculated as approximately 100 in each group.
Sex as a biological variable	Exclusion Criteria HCWs who declined consent, who had a confirmed COVID-19 infection, those who were already taking chloroquine/HCQ for any indication or any other prophylactic drug, pregnant or breast-feeding women, having known co-morbidity or immune-compromised state, having known allergy for the study drug were excluded.

Table 2: Resources

No key resources detected.

Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

The main limitations of our study were that it was done in a single COVID-19 care centre, which was a designated government hospital with a manageable patient load, good infrastructure and robust infection control practices. The risk of exposure here was not as high as general OPD where asymptomatic and mild cases with initial ILI like symptoms may be dealt before diagnosis or in other COVID-19 and non-COVID-19 public sector hospitals with a large patient burden, limited staff, inadequate personal protective equipment and frequent breaches in infection control practices. Secondly the participants were not screened for presence of anti-SARS-CoV-2 IgM and IgG antibodies before inclusion as the study was designed before the first seroprevalance survey in India.35

Results from TrialIdentifier: No clinical trial numbers were referenced.

Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

Results from JetFighter: We did not find any issues relating to colormaps.

Results from rtransparent:

Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
No protocol registration statement was detected.

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