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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/10/037297
Enrollment
500
Registered
2021-10-13
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 Shampoo: Himalaya Gentle Baby Shampoo is a specially formulated mild shampoo that gently cleanses the hair making it soft, shiny and easy to manage. It contains Hibiscus ext

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: Subjects in the age group of 0 to 36 months (inclusive of both genders). Subjects in general good health as determined from a recent medical history and physical examination. Subjects also with dandruff and requiring cleansing of cradle cap 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: A known history or present allergic condition that may require medical attention. Chronic illness which may influence the cutaneous assessment. Subjects not willing to stop the use of other shampoos and during study period.

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and efficacy of Test Product in study population. Primary outcome: 1. Subjective assessment for tangle free and soft & shiny hair 2. Dermatology assessment for mildness and gentleness of babyâ??s skin. Timepoint: Study duration: This study is planned for 15 days. Timepoints: Baseline and 2 weeks.

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMs Sushma C

Himalaya Wellness Company

dr.swathi.b@himalayawellness.com08067547232

Outcome results

None listed

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