An active post marketing surveillance to evaluate the safety and efficacy of a fixed-dose combination of Paracetamol 125mg, Phenylephrine Hydrochloride 5mg and Chlorpheniramine Maleate 1mg per 5mL syrup in symptomatic treatment of common cold in children.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- 1. Proportion of patients reporting adverse events during the study
研究概览
简要总结
Common cold is the most frequently encountered disease in medical practice. It is commonly recognized by a group of symptoms such as sore throat, rhinorrhoea,nasal congestion, coughing, low grade fever, headaches and malaise. Over the counter and flu medicines are the main stay of treatment and aim towards symptomatic relief. It has been found in published literature that the anithistamineanalgesic-decongestant combinations have general benefit in reducing the duration and alleviating the symptoms of common cold. Therefore, combination of Chlorpheniramine maleate (Antihistamine), Paracetamol (Analgesic) and Phenylephrine hydrochloride (decongestant) is an appropriate combination for alleviating symptoms of cold, rhinitis and other upper respiratory tract allergies.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients ≥6 years to <18 years of age
- •Patients with symptoms of common cold of recent onset, for more than 6 hours and less than 72 hours.
- •Children who give assent to participate in the study (For participants between 6 & 12 years, verbal assent is admissible in presence of their parents / Legally Acceptable Representative (LAR).
- •Participants aged between 12 & 18 years should personally sign and date a separately designed, written assent form.).
排除标准
- •Hypersensitivity to any of the ingredients of the formulation.
- •Patients with hepatocellular insufficiency and in patients with hepatic failure or active liver disease.
- •Patients who took an antihistamine, analgesic or decongestant 1 day prior to study enrollment.
结局指标
主要结局
1. Proportion of patients reporting adverse events during the study
时间窗: Day 0 and Day 5
period.
时间窗: Day 0 and Day 5
2. Assessment of therapy by investigators and patients at the end
时间窗: Day 0 and Day 5
of the study period.
时间窗: Day 0 and Day 5
次要结局
- 1. Proportion of patients experiencing reduction in severity of(symptoms.)