CTRI/2021/02/031189
Completed
Phase 4
An active post marketing surveillance to evaluate the safety and efficacy of a fixed-dose combination of Paracetamol 125mg, Phenylephrine Hydrochloride 5mg and Chlorpheniramine Maleate 1mg per 5mL syrup in symptomatic treatment of common cold in children.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Sponsor
- Zuventus Healthcare Limited
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.)
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
Outcomes
Primary Outcomes
Not specified
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