DRKS00003526招募中3 期
Randomised, placebo controlled, prospective, clinical study to investigate the efficacy of Sleep film coated tablets Ze 91019 (Alluna® Nacht zum Einschlafen”, fixed valerian/hops combination) in patients with sleep disorders according to ICD 10 in comparison to valerian mono extract, and hops mono extract - QUISI II
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age = 18 years, informed consent according to AMG (= German Drugs Law); patients with sleep disorders of non-organic origin (ICD 10 F 51.0 - 51.2); Sleep latency = 45 minutes
排除标准
- •febrile illness
- •bronchial asthma
- •voiding disorders
- •dementia or other severe intellectual impairment, which makes an accurate medical history and a valid consent impossible
- •diabetes mellitus
- •Increased cerebral convulsions
- •preference of one sex at the study entry
- •Simultaneous or not at least 4 weeks past participation in other clinical trials
- •skin rash
- •hypnotics and sedatives (other than study medication), psychiatric drugs, tranquilizers (benzodiazepines), antihistamines and beta-blockers
- •parathyroid disease
- •neoplasia
- •Thyroid disease
- •severe heart failure, circulatory failure, severe hepatic or renal insufficiency, severe respiratory insufficiency
- •Stenosis of the stomach and intestines
- •Hypersensitivity to any component of study drug
研究者
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