Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
None listed
Sponsors
Mother Sparsh Baby Care Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects between the ages 3 months to 12 years of either sex. 2. Subjects with acute cold symptoms with nasal and/or chest congestion present for less than or equal to 48 hours. 3. Subjects with at least mild-moderate nasal or chest congestion. 4. Mothers or guardians who agrees to participate their child in this trial and signs a written consent form before the test begins.
Exclusion criteria
Exclusion criteria: 1. Subject with severe systemic illness, fever unstable chronic conditions, immunodeficiency, birth defects, anomalies, or other serious comorbidities that could interfere with study participation or safety. 2. Subjects with known allergy or hypersensitivity to any ingredient in the study product, or a history of asthma triggered by topical aromatic products. 3. Subjects with skin conditions at application site, open wounds, eczema flare, rash, burns, or infection that may interfere with topical application or assessments. 4. Subjects using prohibited medications (topical or systemic decongestants, corticosteroids, antihistamines, or other cold medications) within 24-48 hours prior to enrolment. or those judged by the investigator to be inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the severity scores for cold clinical symptoms.Timepoint: Day 1, Day 4, Day 8, Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the cough severity by parent-reported cough or congestion diary.Timepoint: Day 1, Day 4, Day 8, Day 10;Mean change in the sleep quality score by parent-reported outcomes.Timepoint: Day 1, Day 4, Day 8, Day 10 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed