To evaluate the safety and efficacy of baby tummy roll on in 0-36 months babies.
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2023/10/058786
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Subjects in the age group of 0 to 36 months.
2. Subjects with at least any one condition such as colic pain, indigestion, constipation, gas and bloating.
3. Subjects not using similar products during the study period.
4. Subjects who have not participated in similar clinical trial in the past 4 weeks
5. Subjects in general good health as determined from a recent medical history and physical examination.
6. Subject’s mother/legal guardian willing to give a voluntary written parent consent and agree to complete study activities and come for regular follow up with subject
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 tummy oil or any medication for this indication during study period
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: 3 days,
- Secondary Outcome Measures
Name Time Method ATimepoint: NA