CTRI/2021/02/031189已完成4 期
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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •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.)
排除标准
- •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
研究者
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