Post marketing study to evaluate the Safety and Efficacy of Wikoryl tablets in adult patients
Phase 4
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2022/04/042134
- Lead Sponsor
- Alembic Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients with confirmed clinical diagnosis of common cold
2. Patients who 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 To evaluate the safety of Alembic Wikoryl tabletsTimepoint: Baseline (Day 1) and Day 6
- Secondary Outcome Measures
Name Time Method Change in symptom scores for fever, rhinorrhea, <br/ ><br>nasal congestion and sneezing (Rated on 4 point <br/ ><br>scale 0-3)Timepoint: Baseline and Day 6