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To evaluate the safety and efficacy of baby tummy roll on in 0-36 months babies.

Post Marketing Observational Study PMOS To Evaluate the Safety and Efficacy of HBTM 102109 Baby Tummy Roll On in 0-36 Months Babies - NIL

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058786
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

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Baby tummy roll on: Baby Tummy Roll on is a pure, natural formula that soothes and relaxes babys tummy. This comforting oil is formulated with the gentlest hing oil, saunf oil and calm

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 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

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 tummy oil or any medication for this indication during study period

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: 3 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