Clinical Study of Zandu Junior balm and market preparation in relieving symptoms of cold in Childre
Phase 3
Completed
- Conditions
- Health Condition 1: J984- Other disorders of lung
- Registration Number
- CTRI/2015/04/005707
- Lead Sponsor
- Emami Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•Willing to provide informed consent to participate in the study
•Males or females Child 04-12 years of age both inclusive.
•Diagnosis of Mild to Moderate Headache, Body ache and other symptoms of cough cold.
Exclusion Criteria
•Subjects having persistent headache, body ache or other symptoms which in the opinion of the investigator require proper medical diagnosis and management
•Subjects who have associated moderate to high fever and those who require rescue medicines like analgesics
•Immuno compromised children
•Children allergic to application of products similar to test product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of efficacy of Junior balm in relieving symptoms such as headache, Body ache, and symptoms of common cold like Nasal congestion, sore throat etc. based on VAS and Graded scaleTimepoint: Day 0, Day 2, Day 5 and Day 7
- Secondary Outcome Measures
Name Time Method 1. Assessment of efficacy of Zandu junior Gel Balm in comparison with market preparation in relieving headache, body ache, nasal congestion, sore throat etc. 2. Assessment of number of subjects having relief from symptoms on graded scale 3. Assessment of requirement of rescue medicines 4. Assessment of time taken for relief in the symptoms 5. Global assessment for overall improvement by the investigator and subject 6. Assessment of safetyTimepoint: Day 0, Day 2, Day 5 and Day 7