To Assess the Subjective Effect of Two Paracetamol Preparations on the Feeling of Breathing in Subjects With the Common Cold.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Breathing Scores Post 15 Minutes
研究概览
简要总结
The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of the common cold of no more than 120 hours duration
- •Self-rating congestion of at least moderate severity
- •Suffering from at least four symptoms of common cold or flu
排除标准
- 未提供
研究组 & 干预措施
Paracetamol hot drink
Hot drink containing paracetamol
干预措施: Paracetamol hot drink (Drug)
Paracetamol tablets
Paracetamol tablets
干预措施: Paracetamol tablets (Drug)
结局指标
主要结局
Breathing Scores Post 15 Minutes
时间窗: Baseline to 15 minutes
A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. "my breathing feels easy", "I feel airways are open", "I feel a cooling sensation in my throat", "I can feel the air flowing to my lungs easily", "My nose feels less blocked" and "I feel my breathing is comfortable". The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
次要结局
- Breathing Score Post 60 Minutes(Baseline to 60 minutes)
- Cold Symptoms Score Post 15 Minutes(Baseline to 15 minutes)
- Cold Symptoms Score Post 60 Minutes(Baseline to 60 minutes)
- Soothing Attribute Scores(Baseline to 15 and 60 minutes)
- Overall Cold Symptoms Score(Baseline to 15 and 60 minutes)