Post marketing study to evaluate the Safety and Efficacy of Wikoryl Drops in infants (1 year)
Phase 4
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2021/12/039024
- Lead Sponsor
- Alembic Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age: up to 1 year (weight: 2.5-12 kg)
2. Genders Eligible for Study: both Males and Females
3. Patients with confirmed clinical diagnosis of Common cold with fever
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