Skip to content

A randomized, multicentril, open label, comparative efficacy study in healthy child.

A randomized, open label, multi-center, two arm, comparative efficacy study of Zydus Wellness product ZW3015829 in healthy, children of age 6 to 18 years.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039575
Enrollment
150
Registered
2022-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Zydus Wellness Products Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
- Event of Illness (infection and allergies) in the duration of the study.Timepoint: - 3 month - 6 month

Secondary

MeasureTime frame
Average duration of illnessTimepoint: - 3 month - 6 month;Comparison of Laboratory parameter after illness resolvedTimepoint: - 6 month;Evaluation of physical strength/energy levelTimepoint: - 3 month - 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 - 6 month;Number of children having illnessTimepoint: - 3 month - 6 month;Number of days with reduced physical activityTimepoint: - 3 month - 6 month;Number of treatment daysTimepoint: - 3 month - 6 month;Severity of illnessTimepoint: - 3 month - 6 month;Total days of illness in a groupTimepoint: - 3 month - 6 month

Countries

India

Contacts

Public ContactDr Nilesh Patel

Panexcell Clinical Lab Pvt Ltd

nileshp@panexcell.com9712996613

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026