Effect of baby care products

Not Applicable

Completed

• Registration Number: CTRI/2021/10/037399
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-28
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 216

Inclusion Criteria

1. Subjects in the age group 1-12 months, 12-24 months and 24-36 months in nearly equal ratio. (Both genders inclusive)

2. Subjects in general good health as determined from a recent medical history

3. Subjectââ?¬•s mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up

4. Subjects mother/legal representative, preferably mother willing to abide by and comply with the study protocol

5. Subjects mother/legal representative agreeing not to use any other product of the same nature and change any habit or other regular products during the study period

Exclusion Criteria

1. A known history or present condition or any other concern that may require medical attention

2. Subjects deemed unfit to participate in the study based on the general health and hygiene

3. Babies whose parents and/or authorized legal guardian are not willing to sign the informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pediatrician�s assessment for health and quality of life <br/ ><br>2. Dermatological evaluation for signs of skin irritation and/or discomforts, skin conditionTimepoint: Screening Visit, Baseline Visit, Visit 1 and Visit 2

Secondary Outcome Measures

Name	Time	Method
To evaluate the product acceptance & toleranceTimepoint: Screening Visit, Baseline Visit, Visit 1 and Visit 2