A multicentric, non-randomized, open-label, non-comparative, active post-marketing surveillance study to evaluate the safety and efficacy of Sinarest Plus Suspension in children with 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
- Reduction in mean total symptom score
研究概览
简要总结
Sinarest Plus Suspension is a fixed dose combination of Paracetamol 250 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg, Sodium citrate 60 mg and menthol 1 mg per 5 ml which is indicated for the treatment of common cold in children. The rationale behind this Active Post-Marketing Surveillance study is to document the efficacy and safety of Sinarest Plus Suspension for the treatment of common cold in children. Common cold of viral origin is a self-limiting disease which usually takes up to 10 days to cure by itself. Allergic rhinitis is nasal hypersensitivity symptoms persuaded by an immunologically mediated (predominantly IgE dependent) inflammation as mucous membrane gets exposed to allergens. The signs and symptoms of common cold overlaps with allergic rhinitis and show similar symptoms. 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 initiated the Active Post-Marketing Surveillance study of Sinarest Plus Suspension in children of common cold.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of any age 2 to 12 years having body weight of 6 to 41.5 kg Patients of either sex including male or female Patients with confirmed diagnosis of common cold Patients and guardians who are ready to adhere to the protocol.
排除标准
- •Patients known to be hypersensitive to investigational product Patients with severe Hepatic or Renal dysfunction.
结局指标
主要结局
Reduction in mean total symptom score
时间窗: Day 1, Day 3 and Day 5
Percentage reduction in mean total symptom score at visit 2 and visit 3 as compared to visit 1
时间窗: Day 1, Day 3 and Day 5
次要结局
未报告次要终点
研究者
Dr Mayuresh Kiran
Centaur Pharmaceuticals Pvt Ltd
