â??A Clinical Study to check the Safety and efficacy of HSBP-121901 in babies
- Registration Number
- CTRI/2022/06/043588
- Lead Sponsor
- Himalaya wellness company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
. 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).
. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method