A post-marketing study of the marketed product Maxtra® P Oral Drops for the evaluation of safety and effects in children having common cold.
Phase 4
Completed
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2021/02/031207
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1.Children aged 2 to 5 years.
2.Children with symptoms of common cold of recent onset (lasting for more than 6 hours and less than 72 hours).
3.Parents or Legally Acceptable Representative (LAR) of the children willing to give informed consent and willing to comply with the study protocol.
Exclusion Criteria
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 period. <br/ ><br>2. Assessment of therapy by investigator and parents / LAR at the end of the study period. <br/ ><br>Timepoint: Day 0 and Day 5
- Secondary Outcome Measures
Name Time Method 1. Proportion of patients experiencing reduction in severity of symptoms. <br/ ><br>2. Proportion of patients with complete remission.Timepoint: Day 0 and Day 5