CTRI/2021/02/031390已完成4 期
An active post marketing surveillance to evaluate the safety and efficacy of a fixed-dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 4 mg tablet in symptomatic treatment of common cold in adults.
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 of either gender of age between >=18 years to 60 years.
- •2.Patients with symptoms of common cold of recent onset, for more than 6 hours and less than 72 hours.
- •3.Patients willing to give written informed consent.
排除标准
- •1.Hypersensitivity to any of the ingredients of the formulation.
- •2.Patients taking a monoamine oxidase inhibitor (MAOI), or barbiturates
- •3.Pregnancy or breastfeeding women.
- •4.Patients with hepatocellular insufficiency and in patients with hepatic failure or active liver disease.
- •5.Patients who took an Antihistamine, Analgesic or Decongestant 1 day prior to study enrollment.
- •6.Patients otherwise judged to be inappropriate for inclusion in the study by the investigator
研究者
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