CTRI/2022/06/043588尚未招募2 期
â??An Open label, Clinical Study to Evaluate the Safety and efficacy of HSBP-121901 in babies of 0 â?? 36 months of age
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
- •. Babies in the age group between 0 to 36 months inclusive of both age and genders
- •. Babies in general good health as determined from a recent medical history and the pediatrician.
- •. Baby mother/legal representative preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
- •. Baby mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
- •. Babies should not participate in any other clinical study during participation in the current study.
- •. Babies delivered after complete gestation ( > 38 weeks).
排除标准
- •. Babies with a known history or present condition of allergic response to any other Diapers, toiletries or its components or ingredients as in the test product.
- •. Babies with diarrhea/ bowel incontinence
- •. Babies with diaper rashes or any allergies in the diaper area.
- •. Any pre-existing systemic disease necessitating long term medications and other dermatological problems.
- •. Babies requiring incubators/ ventilators or C-PAP.
- •. Babies who have participated in a similar clinical investigation in the past four weeks.
研究者
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