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To evaluate the safety and efficacy of soothing baby rub in 0-36 months babies.

Post Marketing Observational Study PMOS To Evaluate the Safety and Efficacy of HBCR – 011805 Soothing Baby Rub In 0-36 Months Babies. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058787
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: J069- Acute upper respiratory infection,unspecified

Interventions

Intervention1: Soothing Baby Rub: Soothing baby rub helps baby relax and get rid of a congested nose. Baby rub has many benefits for the baby, like calms, comforts and mild on baby’s skin, helps promo

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. Subject with acute cold symptoms having signs and symptoms as listed below a. Nasal congestion/blockage, b. Itchy nose, c. Sneezing, d. Runny nose. 3. Subjects in general good health as determined from a recent medical history and physical examination. 4. Subjects mother/legal representative willing to give a voluntary written parent consent and agree to comply with the study protocol.

Exclusion criteria

Exclusion criteria: 1. Subjects with a known history or present condition of allergic response to any other vapo rub, balm, or its components or ingredients as in the test product. 2. Subjects having history or present condition of respiratory diseases, or any significant allergies. 3. Subjects requiring medical treatment for the indicated symptoms. 4. Chronic illness which may influence the cutaneous assessment. 5. Subjects who have participated in a similar clinical investigation in the past four weeks

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and efficacy of Test Product in study populationTimepoint: 7 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