A Multicentric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance to evaluate the Safety and Efficacy of Wikoryl 10 tablets in adults suffering from common cold
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- To evaluate the safety of Wikoryl 10 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 Wikoryl 10 tablets(fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10mg, Chlorpheniramine Maleate 2 mg) in adults suffering from Common cold. Thestudy will be conducted at 4-6 specialty sites and at each site 40-60 adultswill be recruited as per the inclusion and exclusion criteria by theinvestigator. The active PMS will be conducted for the duration of 5 days bythe investigator. At day 1 (baseline) the patient will be informed about thestudy procedure and if agreed then his/ her sign on the informed consent formwill 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 takethe required medication in the dose of 1 tablet, 3 to 4 times in a day or asdirected by investigator for the period of 5 days starting from Day 1 (Visit1). Also patient will be asked to visit to the clinical trial site at day 6 forsafety 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)（—）
入选标准
- •1.Age: > 18 years 2.Genders Eligible for Study: both Males and Females 3.Patients with confirmed clinical diagnosis of common cold 4.Patients who can adhere to the Protocol.
排除标准
- •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 Wikoryl 10 tablets
时间窗: upto Day 6
次要结局
- Change in symptom scores for fever, rhinorrhea,(nasal congestion and sneezing (Rated on 4 point scale 0-3))