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To evaluate the safety and efficacy of gentle baby soap in 0-36 months babies.

PMOS to evaluate the safety and efficacy of gentle baby soap in 0-36 months babies.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/10/037322
Enrollment
500
Registered
2021-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

None listed

Interventions

Intervention1: Gentle Baby Soap: Himalaya Gentle Baby soap leaves babyâ??s skin soft and supple, it contains Almond oil and Olive oils to gently cleanse and moisturize babyâ??s skin and it also rich i

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 (inclusive of both genders) 2. Subjects in general good health as determined from a recent medical history and physical examination 3. Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to comply with the study protocol

Exclusion criteria

Exclusion criteria: 1. A known history or present allergic condition that may require medical attention 2. Chronic illness which may influence the cutaneous assessment 3. Subjects not willing to stop the use of other soaps during study period

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and efficacy of Test Product in study populationTimepoint: Study duration: This study is planned for 15 days

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMs Sushma C

Himalaya Wellness Company

dr.swathi.b@himalayawellness.com8067547232

Outcome results

None listed

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