A randomized, multicentril, open label, comparative efficacy study in healthy child.
- Registration Number
- CTRI/2022/01/039575
- Lead Sponsor
- Zydus Wellness Products Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or Female child between 6 years to 18 years of age.
2. Parents providing written informed consent and are willing to participate in the study.
3. Providing accent for trial (if participant age >11 years of age)
4. Parent agrees to provide milk/product as instructed.
5. No any active sign/symptom of illness, disease or disorder or any co morbidities such as IDDM as evaluated by Physician.
1. Child who has hypersensitivity to any drug or food product or nutritional product or Ayurvedic product.
2. Child taking medicine for any disease or disorder.
3. Child diagnosed with clinical disease or disorder including malnutrition or anemia which require therapeutic treatment.
4. Child with history of surgery within last 3 months of participation.
5. Child participated in any other clinical trial within last 3 months.
6. Investigator opinion on any foreseen subject non-compliances towards study protocol during the study execution.
7. Child height or weight is less than 13 percentile as per Indian Khadilkar Growth Chart.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Event of Illness (infection and allergies) in the duration of the study.Timepoint: - 3 month <br/ ><br>- 6 month
- Secondary Outcome Measures
Name Time Method Average duration of illnessTimepoint: - 3 month <br/ ><br>- 6 month;Comparison of Laboratory parameter after illness resolvedTimepoint: - 6 month;Evaluation of physical strength/energy levelTimepoint: - 3 month <br/ ><br>- 6 month;Measurement of Anthropometric parameters (height and Weight) at baseline and end of studyTimepoint: - 6 month;Measurement of BMI at baseline and end of studyTimepoint: - 6 month;No of absent days due to illnessTimepoint: - 3 month <br/ ><br>- 6 month;Number of children having illnessTimepoint: - 3 month <br/ ><br>- 6 month;Number of days with reduced physical activityTimepoint: - 3 month <br/ ><br>- 6 month;Number of treatment daysTimepoint: - 3 month <br/ ><br>- 6 month;Severity of illnessTimepoint: - 3 month <br/ ><br>- 6 month;Total days of illness in a groupTimepoint: - 3 month <br/ ><br>- 6 month