An Open label, Clinical Study to Evaluate the Safety and efficacy of HSBP-121901 in babies of 0 Ã¢â?¬â?? 36 months of age

The Himalaya Drug Company0 个研究点目标入组 40 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Babies in the age group of 0 to 36 months (inclusive of both genders)
•2. Babies in general good health as determined from recent medical history and the Pediatrician.
•3. BabyÃ¢â?¬•s mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
•4. BabyÃ¢â?¬•s mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
•5.Babies should not participate in any other clinical study during participation in the current study.
•6. Babies delivered after complete gestation ( > 38 weeks).

•1. 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.
•2. Babies with diarrhea/ bowel incontinence
•3. Babies with diaper rashes or any allergies in the diaper area.
•4. Any pre-existing systemic disease necessitating long term medications and other dermatological problems.
•5. Babies requiring incubators/ ventilators or C-PAP.
•6. Babies who have participated in a similar clinical investigation in the past four weeks.

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