An active post marketing surveillance study to evaluate the safety and efficacy of a fixed dose combination of Paracetamol 250 mg, Phenylephrine Hydrochloride 5mg and Chlorpheniramine Maleate 2 mg per 5ml syrup in symptomatic treatment of common cold in children.

Zuventus Healthcare Limited0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•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

发起方