None listed
Conditions
Interventions
Intervention1: HSBP-121901: Pull out one diaper pant from the pack, pull the
pant to fit baby�s waist and ensure that the waist area is
not folded over. Use daily
Control Intervention1: Not App
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mildness gentleness and irritation as assessed by pediatrician assessment Scoring 2. subjective questionnaire for - helps to prevent diaper rash less frequent change of diapers Withstand multiple wetting overnight use Undisturbed restful sleep for the baby Less crying less cranky after waking up Provides soft and tender care with less friction of the diaper No incidence of leakage of urine or feces Ease of diaper application and removal overall satisfaction of the productTimepoint: Day 1 (Baseline) and Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Local intolerance of the product assessed by Pediatrician 2. Continuous monitoring of adverse event during the study period.Timepoint: Day 1 (Baseline) and Day 8 | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed