CTRI/2022/04/041890已完成未知
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.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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