Active post marketing surveillance to evaluate the safety and efficacy of Sinarest Syrup in children of common cold or allergic rhinitis.
Phase 4
Completed
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]Health Condition 2: J309- Allergic rhinitis, unspecified
- Registration Number
- CTRI/2021/11/037912
- Lead Sponsor
- Centaur Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 417
Inclusion Criteria
1. Age: between 2 to 12 years (weight: 6-40 kg)
2. Genders eligible for Study: both Males and Females
3. Patients with confirmed clinical diagnosis of common cold or allergic rhinitis
4. Patients whose guardians can adhere to the Protocol
Exclusion Criteria
1. Patients known to be hypersensitive to investigational product
2. Patients with severe Hepatic or Renal dysfunction
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method