MedPath

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

Phase 4
Conditions
Health Condition 1: J069- Acute upper respiratory infection,unspecified
Registration Number
CTRI/2023/10/058787
Lead Sponsor
Himalaya Wellness Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the safety and efficacy of Test Product in study populationTimepoint: 7 days.
Secondary Outcome Measures
NameTimeMethod
ATimepoint: NA
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