CTRI/2021/02/031207已完成4 期
An active post marketing surveillance study to evaluate the safety and efficacy of a fixed-dose combination of Paracetamol 125 mg, Phenylephrine Hydrochloride 2.5 mg and Chlorpheniramine Maleate 1 mg oral drops 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.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.
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
相似试验
已完成
4 期
A post-marketing study of the marketed product Maxtra® PDS syrup for the evaluation of safety and effects in children having common cold.CTRI/2021/02/031188Zuventus Healthcare Limited200
进行中（未招募）
4 期
A post-marketing surveillance study to evaluate the safety and immunological response of typhoid conjugate vaccine in healthy subjectsCTRI/2021/11/037996Cadila Healthcare Limited
已完成
4 期
A Study to assess the safety of Vildagliptin Tablets 100 mg available in market.CTRI/2023/07/055146Eris Lifesciences Ltd.205
进行中（未招募）
4 期
A Clinical trial to evaluate the safety of measles & Rubella vaccine in healthy child having the age of 9 to 12 monthsCTRI/2022/10/046225Zydus Lifesciences Limited
招募中
4 期
A post marketing study to evaluate safety and effectiveness of Remogliflozin and Remogliflozin-Metformin Combination in treatment of Diabetes patientsCTRI/2019/11/022062Glenmark Pharmaceuticals Ltd