Safety and efficacy of baby diaper pant
- Registration Number
- CTRI/2020/10/028193
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 40
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. Babyââ?¬•s mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
4. Babyââ?¬•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mildness gentleness and irritation as assessed by <br/ ><br>pediatrician assessment Scoring <br/ ><br>2. subjective questionnaire for - helps to prevent diaper rash <br/ ><br>less frequent change of diapers Withstand <br/ ><br>multiple wetting <br/ ><br>overnight use Undisturbed restful <br/ ><br>sleep for the baby <br/ ><br>Less crying <br/ ><br>less cranky after <br/ ><br>waking up <br/ ><br>Provides soft and tender care with less <br/ ><br>friction of the diaper <br/ ><br>No incidence of leakage of <br/ ><br>urine or feces <br/ ><br>Ease of diaper application and removal <br/ ><br>overall satisfaction of the productTimepoint: Day 1 (Baseline) and Day 8
- Secondary Outcome Measures
Name Time Method 1. Local intolerance of the product assessed by <br/ ><br>Pediatrician <br/ ><br>2. Continuous monitoring of adverse event during the <br/ ><br>study period.Timepoint: Day 1 (Baseline) and Day 8