Clinical Study on Dabur Chyawanprash in Health & Immunity related Parameters in Healthy childre
- Registration Number
- CTRI/2015/02/005574
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 702
1 Healthy children of either sex of 5-12 years (both inclusive)
2 Ready to provide informed consent from parent/ legally accepted guardian
3 No significant medical or surgical disease/s at the time of screening
4 No history of allergic conditions to Chyawanprash like products/any ingredients of the Chyawanprash and are not averse to consuming Chyawanprash for the study period
5 Willing to come for the follow up visits for evaluation
1 Presence of any clinically significant medical or surgical condition requiring long term treatment
2 Subjects participating/participated in another clinical study within 3 months before recruitment
3 Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation
4 Immunologically compromised children
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of immunity through episodes severity and duration of illness (infections or allergies) in the two study groups based on subject diaryTimepoint: 180 days (6 months)
- Secondary Outcome Measures
Name Time Method Assessment will done in two study groups - immunity through no of children having infections or allergies, difference of absent days in school due to infections or allergies,no of children for absent days in school due to infections or allergies, change in energy levels, physical fitness, strength and stamina and no of children having change in energy levels, physical fitness, strength &stamina & change in quality of life & Physicians Global evaluation on CGI-I Scale and safety and tolerabilityTimepoint: 180 days (6 Months)