None listed
Conditions
Interventions
None listed
Sponsors
Himalaya wellness company
Eligibility
Inclusion criteria
Inclusion criteria: . 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).
Exclusion criteria
Exclusion criteria: . 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| . Mildness, Gentleness and irritation as assessed by Pediatrician Assessment Scoring. . Local intolerance of the product assessed by Pediatrician. . Helps to prevent diaper rash, less frequent change of diapers, Withstand multiple wettings, 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 faeces, Ease of diaper application and removal, overall satisfaction of the product by subjective questionnaire Timepoint: Day 1 and Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety of product by reporting of all adverse events during the study period.Timepoint: Day 1 and Day 8 | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya wellness company
Outcome results
None listed