Prescriber Based, Post Marketing Surveillance Study (PMS) to generate safety and efficacy data of Febrex Plus Syrup
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To generate safety data of Febrex Plus Syrup
研究概览
简要总结
The common cold and influenza are among the mostfrequent of illnesses and a cure, at least for the cold, is still some way off.However, for the most part both are relatively mild and self-limitingconditions with a well-defined range of symptoms. Therefore, for mostindividuals, a reduction in symptom severity is a reasonable substitute foroutright cure.
The aim of this prescriber based post marketingsurveillance is to assess efficacy & safety of Febrex Plus Syrup in the actual field conditions of use.
All patientsclinically manifesting with symptoms of common cold & cough and who have been prescribed Febrex Plus Syrup in the recommended dose ofwill be assessed for efficacy and safety. Patients will usually be called forfollow-up on the day convenient to them and will be judged on the bases ofenquiry & clinician impression.
Adverse event reporting will be done using PMS formsupplied by Medical Representative. Patients will be questioned about anyadverse experience during the treatment period (Both anticipated and unexpected side effects)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Year(s) 至 2.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex of age 00 to 02 years [both inclusive] 2.Willing to give written informed consent 3.All patients clinically manifesting with symptoms of common cold & cough.
排除标准
- •Patients known, or thought to be hypersensitivity to study drug 2)History of auto-immune disease 3)Concurrent use of corticosteroids 4)Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion 5)Participation in other clinical trials the last three months and during study participation 6)Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs 7)Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control 8)Patients with galactose or fructose intolerance 9)Patients with severe renal impairment, including those receiving dialysis.
- •Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
- •Patients with preexisting gallbladder disease 12)Active peptic ulcer disease.
结局指标
主要结局
To generate safety data of Febrex Plus Syrup
时间窗: 5 days
次要结局
- To generate efficacy data of Febrex Plus Syrup(5 days)