CTRI/2020/07/026402已完成4 期
A Prospective, Interventional, Multicenter, Post marketing Clinical Study of fixed dose combination of FLUCOLD TABLET (Paracetamol 500 mg + Phenylephrine HCL 10 mg + Chlorpheniramine maleate 2 mg) Uncoated tablet of Wallace Pharmaceutical Pvt. Ltd., in the Treatment of common cold and flu syndrome in adult population.
Wallace Pharmaceuticals Pvt Ltd0 个研究点目标入组 199 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 199
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or Female having the age of 18 to 55 years.
- •2.Presented symptoms of recent onset, for more than 6 hours and less than 72 hours, characterizing one of the following conditions:
- •The common cold, which consists of at least 2 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, the latter being of moderate to severe intensity through a symptom severity scale of 4 points
- •3. Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
排除标准
- •1.Patients who are not willing to give written informed consent.
- •2.Any known hypersensitivity to the study products.
- •3.Pregnant and lactating women.
- •4.Any history of seasonal or perennial allergic rhinitis.
- •5.Patients who have taken treatment for the presenting symptom within 7 days of screening.
- •6.Any history of drug abuse /chronic alcoholism
- •7.Use of monoamine oxidase inhibitors or barbiturates
- •8.Use of Vitamin C/ascorbic acid or taking supplements or fruits rich in vitamin C.
研究者
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