NCT00552981已完成不适用
Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Symptom Score for Common Cold
研究概览
简要总结
In a randomized controlled trial, the investigators include patients with beginning symptoms of a common cold and compare two interventions:
- the inhalation of warm air for inducing a warming of the throat and
- the inhalation of ambient air as control. As outcome the effect on symptoms and duration of the common cold will be assessed. The interventions will consist of visits with a duration of 2-3 minutes on three following days in a Finnish sauna. Patients will be fully dressed.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptom duration between 2 and 24 hours
- •at least two of the ten following symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever
- •no usage of medication bought in a pharmacy
- •informed consent
排除标准
- •fever >38.5°C
- •systolic blood pressure below 100 mmHg or above 160 mmHg
- •severe chronic disease, which makes study participation impossible
- •pregnancy
研究组 & 干预措施
1
Active Comparator
干预措施: inhalation of warm air in a Finnish sauna (Procedure)
2
Sham Comparator
干预措施: inhalation of ambient air in a Finnish sauna (Procedure)
结局指标
主要结局
Symptom Score for Common Cold
时间窗: Area under the curve day 2 to 7
次要结局
- Usage of medication against common cold(Day 1 to 7)
- generalized feeling ill on a numeric rating scale 0-10,(Day 1, 2, 3, 5 and 7)
- safety (adverse events and serious adverse events)(1 to 7 days)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany
研究点 (1)
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