Prescriber Based, Post Marketing Surveillance Study (PMS) to generate safety and efficacy data of Sneezy Oral Suspension
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary aim of this prescriber based post marketing surveillance is to assess safety and efficacy of Sneezy Oral Suspension in the actual field conditions of use.
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 primary aim of this prescriber based postmarketing surveillance is to assess safetyand efficacy of Sneezy Oral Suspension in the actual field conditions of use. The secondaryaim of this prescriber based post marketing surveillance is to assess efficacy of Sneezy OralSuspension in the actual fieldconditions of use.
All patientsclinically manifesting with symptoms of common cold & cough and who have been prescribed Sneezy oral SUSPENSION in the recommended doses will be assessed for efficacy and safety. Patientswill usually be called for follow-up on the day convenient to them and will be judged on the bases of enquiry & clinician impression.
Adverse event reporting will be done using PMS formsupplied by Medical Representatives. 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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex of age 18 to 60 years [both inclusive] 2.Willing to give written informed consent 3.All patients clinically manifesting with symptoms of common cold and influenza.
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
The primary aim of this prescriber based post marketing surveillance is to assess safety and efficacy of Sneezy Oral Suspension in the actual field conditions of use.
时间窗: 7 days
次要结局
- The secondary aim of this prescriber based post marketing surveillance is to assess efficacy of Sneezy Oral Suspension in the actual field conditions of use.(7 days)