A post-marketing study of the marketed product Maxtra® P syrup for the evaluation of safety and effects in children having common cold.
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2021/02/031189
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Patients =6 years to <18 years of age
2. Patients with symptoms of common cold of recent onset, for more
than 6 hours and less than 72 hours.
3. Children who give assent to participate in the study (For participants
between 6 & 12 years, verbal assent is admissible in presence of their
parents / Legally Acceptable Representative (LAR). Participants aged
between 12 & 18 years should personally sign and date a separately
designed, written assent form.)
1. Hypersensitivity to any of the ingredients of the formulation.
2. Patients with hepatocellular insufficiency and in patients with hepatic
failure or active liver disease.
3. Patients who took an antihistamine, analgesic or decongestant 1 day
prior to study enrollment.
4. Patients otherwise judged to be inappropriate for inclusion in the
study by the investigator
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of patients reporting adverse events during the study <br/ ><br>period. <br/ ><br>2. Assessment of therapy by investigators and patients at the end <br/ ><br>of the study period.Timepoint: Day 0 and Day 5
- Secondary Outcome Measures
Name Time Method 1. Proportion of patients experiencing reduction in severity of <br/ ><br>symptoms. <br/ ><br>2. Proportion of patients with complete remission.Timepoint: Day 0 and Day 5