EUCTR2016-000160-42-AT进行中（未招募）1 期
Effect of inhaled budenoside on the incidence and severity of Acute Mountain Sickness at 4559 m - Inhaled budenoside and AMS
K für Anästhesiologie und allgemeine Intensivmedizin0 个研究点目标入组 51 人开始时间: 2016年3月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age 18-60 years
- •-Good physical condition
- •-No relevant pathologies upon the pre-examination prior to the study
- •-Written informed consent to participate in the study
- •-Males and females are included without prioritization
- •-Permanent residency below 1000 m
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 51
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Acute and chronic lung diseases
- •-Conventional systolic blood pressure (average of two measurements) =150 mmHg and conventional diastolic blood pressure =95 mmHg in untreated or treated subjects Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, peripheral artery disease)
- •-Chronic headache / migraine
- •-Diabetes mellitus
- •-Smoking (>6 cigarettes/day) or equivalent nicotine substitutes
- •-Alcohol (>30 g/d) or drug abuse
- •-Obesity (Body Mass Index >30)
- •-Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders)
- •-Sojourn >2000 m within the last 4 weeks before the 1st study day
- •-Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality (eg. corticosteroids) or the safety of the participants (eg. anti- coagulants)
- •-Blood donation within the last 2 month before the 1st study day
研究者
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