CTRI/2022/04/041890
Completed
未知
A clinical study to evaluate the safety and efficacy of the baby care products on a healthy pediatric population of the age group 01-36 months.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Marico Limited
- Enrollment
- 37
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects in the age group 1\-12 months, 12\-24 months and 24\-36 months in nearly equal ratio (both genders inclusive)
- •2\. Subjects in general good health as determined from a recent medical history
- •3\. Subject’s mother/authorized legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
- •4\. Subject’s mother/authorized legal representative, preferably mother willing to abide by and comply with the study protocol.
- •5\. Subject’s mother/legal representative agreeing not to use any other product of the same nature and change any habit or other regular products during the study period.
Exclusion Criteria
- •1\. A known history or present condition or any other concern that may require medical attention
- •2\. Subejcts deemed unfit to participate in the study based on the general health and hygiene.
- •3\. Babies whose parents and/or authorized legal guardian are not willing to sign the informed consent.
Outcomes
Primary Outcomes
Not specified
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