DaburPrimary
The primary outcome was comparative incidence of COVID-19 and other non-COVID-19 infections over 90 days.
COVID-19 infection was assessed using RT-PCR/antigen testing, while clinical severity was assessed using the WHO ordinal scale.
Clinical Study 4 · Randomised · Multicentric · Comparative
Clinical Evaluation of Chyawanprash During the COVID-19 Pandemic
CTRI/2020/05/024981, dated 2 May 2020
Title. Clinical Evaluation of Chyawanprash as a Preventive Measure During the COVID-19 Pandemic: An Open-label, Multicentric, Randomized, Comparative, Prospective, and Interventional Community-based Clinical Study on Healthy Individuals.
COVID-19 incidence over 90 days
2.38%
DCP group, against 28.57% in the control group. P < 0.05, statistically significant
Population
5 to 70 years
Healthy males and females
Sites
5
Across Maharashtra, Gujarat and Rajasthan, May to November 2020
Randomised
721
696 efficacy-evaluable/completers
Intervention period
90 days
DCP versus milk control
Study flow
771
Screened
721
Randomised
DCP 362Control 359
696
Efficacy-evaluable
DCP 351Control 345
Eligibility and intervention
Healthy males and females aged 5–70 years were eligible. Pregnant/lactating women, persons with confirmed/recent COVID-19, diabetes, significant medical conditions, immunocompromised status, steroid/immunosuppressive treatment and other specified conditions were excluded.
DCP group
13 to 70 years: 12 g twice daily
5 to 12 years: 6 g twice daily, followed by about 200 mL milk.
Control group
About 200 mL milk
Twice daily.
Outcome measures
Secondary
- COVID-19 severity according to WHO ordinal scale
- Hospitalization
- Duration of hospitalization
- ICU admission
- Ventilator support
- Mortality
- Incidence/severity of cough, sneezing, rhinitis and sore throat
- Quality of life using Q-LES-Q-SF
- Overall efficacy and safety
COVID-19 findings
Efficacy-evaluable subjects| DCP · N = 351 | Control · N = 345 | |
|---|---|---|
| Tested by RT-PCR or antigen | 42 | 28 |
| COVID-19 positive | 1 | 8 |
| Incidence | 2.38% | 28.57% |
The study reports the incidence in the DCP group as statistically significantly lower than in the control group.
The study also reports that the COVID-19-positive subject in the DCP group had mild symptoms, whereas the eight positive subjects in the control group had symptoms ranging from mild to severe. No ICU admission was required in the DCP group.
Influenza-like illness and quality of life
DCP · N = 351
41
subjects · 11.68%
Control · N = 345
43
subjects · 12.46%
The study reports a statistically significant improvement in quality of life in the DCP group, assessed using Q-LES-Q-SF.
Safety
Physician assessment · DCP
Excellent 63.53%Good 32.19%Fair 4.27%Poor 0%
Participant self-assessment gave similar results.
- Total AE episodes, DCP
- 52
- Total AE episodes, control
- 54
- Serious adverse events, DCP
- 1
- Serious adverse events, control
- 5
- SAEs related to the study product
- 0
A total of 106 adverse-event episodes were reported. Most DCP-group AEs were assessed as unrelated to DCP. Two events were considered possibly related: pruritus ani and mild skin allergy. Both were mild and resolved with symptomatic treatment.
Six serious adverse events occurred in total, one in the DCP group and five in the control group; none was considered related to the study product.
Key takeaway
Chyawanprash demonstrated a significantly lower incidence of COVID-19 than control over 90 days.
- No ICU admission was required in the DCP group, and the single case was mild. Influenza-like illness was comparable between groups.
- Quality of life improved significantly with DCP, which was well tolerated with no study-drug-related serious adverse events.
RT-PCR, reverse transcriptase polymerase chain reaction. ICU, intensive care unit. Q-LES-Q-SF, Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form. WHO, World Health Organization.