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To evaluate the safety and efficacy of baby powder with pure corn starch in 0-36 months babies

Post Marketing Observational Study PMOS To Evaluate the Safety and Efficacy of Baby Powder with Pure Corn Starch HBTF – 042102 In 0-36 Months Babies. - NIL

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058785
Enrollment
500
Registered
2023-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Baby powder with pure corn starch: The skin of an infant is sensitive, thin and fragile. Baby’s skin needs extra care and protection as it is softer, more sensitive and more delicate co
Aloe Vera helps in soothing babys delicate skin. Frequency-After Bathing, after nappy changes, before bedtime Rout- Topical Frequency -14 Days Control Intervention1: NA: NA

Sponsors

Himalaya Wellness Company
Lead Sponsor
JSS Medical Research Asia Pacific Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects in the age group of 0 to 36 months. 2. Subjects in general good health as determined by investigator. 3. Subjects mother/legal representative willing to give a voluntary written parent consent and agree to complete study activities and come for regular follow up with subject.

Exclusion criteria

Exclusion criteria: 1. A known history or present condition of chronic allergic response to any other concern that may require medical attention or requiring systemic treatment. 2. Chronic illness which may influence the cutaneous assessment. 3. Subjects not willing to stop the use of other baby powder. 4. Any subject, in the investigators opinion not considered suitable for enrolment.

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and efficacy of Test Product in study population. Safety and efficacy will be assessed at the end of the study visit. Timepoint: 14 days

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Swathi B

Himalaya Wellness Company

dr.sooryanarayan.h@himalayawellness.com918067549919

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026