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临床试验/CTRI/2020/07/026402
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

发起方
Wallace Pharmaceuticals Pvt Ltd

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