“Clinical evaluation of Dabur Chyawanprash (DCP) as a preventive remedy in pandemic of COVID-19 – An Open label, Multi centric, Randomized, Comparative, Prospective, Interventional Community based Clinical Study on Healthy individuals.â€

The study was intended to evaluate DCP as a preventive remedy for COVID-19 and other non COVID-19 infections in an open labelled, Multi centric, Randomized, Comparative, Interventional, Prospective Community based design in healthy male and female individuals aged between 5-70 years. The total completers of the study were 696 subjects. A total  721 subjects were recruited in the study.  The study was carried out at the study sites and at community level. Screening of subjects was done after receiving approval from the IEC of the respective site & registration of the study with CTRI.As per computer generated randomization list, subject were assigned, either Group A or Group B. Subject from Group A was provided with 500 gm Jar(s) of Chyawanprash for 45 days (50 gm extra in case follow up is delayed by 5 days). Subjects were advised to take DCP in a dose of one teaspoon twice daily (10 gm) (adults 12-years to 70 years) and ½ teaspoon (5 gm) twice daily (Children 5-12 years) followed by milk (approx. 200 ml) for 90 days. Subjects in Group B were not be provided with any study drug and were asked to take one cup of milk (approx. 200 ml) for 90 days. Both the groups were advised to follow their normal/routine and diet which they are currently following. All participating subjects were asked to follow COVID-19 related guidelines (prevention and containment of infection) provided by the local health authorities and other government agencies from time to time. Any mass mandatory remedy recommended by the Government of India/State or Local Health Authorities will be given to the participating subjects of both the groups. Data was captured in E-CRFs and E- Diaries. Comparative assessment of incidence of COVID-19  and other infections in subjects taking DCP and those not taking it over a period of 3 months (90 days) were assessed as primary outcome. Severity of COVID-19, incidences of hospitalisations etc, incidence and severity of other infections and allergies, QOL, GCI and safety assessments were measured as secondary outcomes.

Results & Conclusion: The study showed encouraging results as preventive remedy in COVID-19 infection. Thestudy concludes that Dabur Chyawanprash plays a significant role in theprevention of infections including COVID-19 infection in the current pandemic. Theseverity of infections related illnesses including COVID-19 also were lowerwith the consumption of Dabur Chyawanprash.

Whencompared between the groups, statistically significantly  lesser number of subjects were found to be infectedwith COVID-19 in DCP group as compared to subjects in the control group

Whencompared between the groups, statistically significant lesser number of subjects having COVID-19 relatedsymptoms tested positive for COVID-19 in DCP group as compared to subjects incontrol group

Whencompared between the groups, statistically significant lesser number of episodes of illness related toinfection/Immunity (Non-COVID-19) were observed in DCP group as compared tocontrol group

WHO ordinal scale showedhigher total scores of severity in control group as compared to DCP group atinitial level, during the course of the study and the end of the study,signifying lower severity of COVID-19 in subjects taking DCP.

DaburChyawanprash also helped to improve the quality of life and was found to besafe for consumption. In view of the data, Dabur Chyawanprash could be one ofthe prophylactic choices in the management and control of pandemic likeCOVID-19.