None listed
Conditions
Interventions
Intervention1: Dabur Chyawanprash: Dosage and Treatment Duration:
Adults (13 -70 years): One teaspoonful (approx. 12 gm of Chyawanprash) twice daily followed by milk
Children (5-12 years): Half teasp
Sponsors
Dabur India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be included in the trial- 1. Healthy, Male or Female subjects between the age group of 5 years to 70 years (both inclusive). Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring and treatment. 2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
Exclusion criteria
Exclusion criteria: 1.Pregnant and Lactating females 2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. Subjects having recently suffered and recovered of COVID-19 will also be excluded from the study 3. Known cases of Diabetes 4. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. 5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy 6. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. 7. Subjects having a past history of allergy to Chyawanprash like products 8. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Comparative assessment of incidence of COVID-19 in subjects taking DCP and those not taking it over a period of 3 months (90 days) 2. Comparative assessment of incidence of other non COVID-19 infections in subjects taking DCP and those not taking it over a period of 3 months (90 days) Timepoint: Day 15,30, 45, 60, 75, 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparative assessment of severity of COVID-19 (when it occurs) in subjects taking DCP and those not taking it. Severity will be graded as per the attached ordinal scale for clinical improvement of COVID-19 published by WHO Timepoint: Day 15,30, 45, 60, 75, 90;Comparative assessment of changes in Quality of life evaluated on Q-LES-Q-SFTimepoint: Day 0,45,90;Comparative assessment of incidence and severity of other allergy related health problems like cough, sneezing, rhinitis, sore throat etc.Timepoint: Day 15,30, 45, 60, 75, 90;Comparative assessment of number of subjects requiring hospitalization, number of days of hospitalization, number of subjects requiring ICU admission and number of subjects requiring Ventilator support and mortality rate.Timepoint: Day 15,30, 45, 60, 75, 90;Global assessment of overall change as per the investigator (Efficacy assessment)Timepoint: Day 90;Safety assessment by evaluation of occurrence of AE/SAETimepoint: Day 0, 15,30, 45, 60, 75, 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed