A multicentric, non-randomized, open label, non-comparative, active post marketing surveillance (PMS) study to evaluate the safety and efficacy of Sinarest Oral Drops in infants of common cold.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 4
- 主要终点
- 1.Reduction in mean total symptom score
研究概览
简要总结
Sinarest Oral Drops is a fixed dose combination of Paracetamol 125 mg, Phenylephrine hydrochloride 2.5 mg and Chlorpheniramine maleate 1 mg per ml which is indicated for the treatment of common cold. The rationale behind this ‘Active Post-Marketing Surveillance study’ is to document the efficacy and safety of Sinarest Oral drops for the treatment of common cold in infants. common cold of viral origin is a self-limiting disease which usually takes up to 10 days to cure by itself. Most of the patients suffer from common cold is due to viral infection of page upper respiratory tract. According to the guidelines of DPHHS and Cochrane review combination of analgesic, antihistaminic and decongestant medication can be used for the treatment of common cold. Taking this into consideration we have proposed Active Post-Marketing Surveillance study of Sinarest Oral Drops in infants of common cold.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Year(s) 至 1.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of age up to 1 year having body weight of up to 11.8 kg Patients of both genders including male and female.
- •Patients with a confirmed diagnosis of common cold Patients whose guardians are ready to sign the informed consent form and can adhere to the protocol.
排除标准
- •Patients hypersensitive to the investigational product Patients with severe Hepatic or Renal dysfunction.
结局指标
主要结局
1.Reduction in mean total symptom score
时间窗: Day 1, day 3 and day 5
2.Percentage Reduction in mean total symptom
时间窗: Day 1, day 3 and day 5
score
时间窗: Day 1, day 3 and day 5
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Mayuresh Kiran
Centaur Pharmaceuticals Pvt Ltd
