A Multicentric, Non-Randomized, Open label, Non-Comparative, Active post marketingsurveillance to evaluate the Safety and Efficacy of Alembic Wikoryl tablets in adults sufferingfrom common cold
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- To evaluate the safety of Alembic Wikoryl tablets
研究概览
简要总结
It will be a Multicentric, Non-Randomized, Open label, Non-Comparative, Active PMS to evaluate the Safety and Efficacy of Alembic Wikoryl tablets (fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg) in adults suffering from Common cold. The study will be conducted at 4-6 specialty sites and at each site 40-60 adults will be recruited as per the inclusion and exclusion criteria by the investigator. The active PMS will be conducted for the duration of 5 days by the investigator. At day 1 (baseline) the patient will be informed about the study procedure and if agreed then his/ her sign on the informed consent form will be taken and patient will be recruited for the active PMS of Wikoryl 10 tablets. Based on the prescription of the principle investigator the patient will take the required medication in the dose of 1 tablet, 3 to 4 times in a day or as directed by investigator for the period of 5 days starting from Day 1 (Visit 1). Also patient will be asked to visit to the clinical trial site at day 6 for safety and efficacy assessment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with confirmed clinical diagnosis of common cold
- •Patients who can adhere to the Protocol.
排除标准
- •1.Patients known to be hypersensitive to investigational product 2.Patients with severe Hepatic or Renal dysfunction.
结局指标
主要结局
To evaluate the safety of Alembic Wikoryl tablets
时间窗: Baseline (Day 1) and Day 6
次要结局
- Change in symptom scores for fever, rhinorrhea,(nasal congestion and sneezing (Rated on 4 point)
