Active post marketing surveillance to evaluate the Safety and Efficacy of Sinarest New Tablet in adults 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/2021/11/037857
- Lead Sponsor
- Centaur Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 420
Inclusion Criteria
1. Patients of age > 18 years and < 65 years.
2. Patients of either sex including male or female.
3. Patients with confirmed clinical diagnosis of common cold or allergic rhinitis
4. Patients who can strictly adhere to the protocol and ready to sign the informed consent form.
Exclusion Criteria
1. Patients known or thought to be hypersensitive to the investigational product.
2. Patients with severe hepatic or renal dysfunction.
3. Pregnant or lactating women.
4. Patients who cannot adhere to the protocol (Mentally ill or patients with the psychological problems.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Reduction in mean total symptom score <br/ ><br>2.Percentage reduction in mean total symptom scoreTimepoint: Day 1, day 3 and day 5
- Secondary Outcome Measures
Name Time Method ot applicableTimepoint: Not applicable