NCT00997256已完成1 期
Phase I, Placebo-controlled, Double-blind, Randomised, Single-centre Study of Single Cross-over Design to Investigate the Effects of the Herbal Preparation Neurapas® Balance Compared With Placebo on Sleep EEG, Mental Performance and Well-being
Pascoe Pharmazeutische Praeparate GmbH1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)
研究概览
简要总结
To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and valerian on sleep structure, improvement of attention, and well-being in comparison to placebo.
详细描述
To demonstrate the influence of the herbal combination preparation Neurapas® balance on the objective sleep structure in comparison with placebo. A further aim was to investigate whether treatment with Neurapas® balance versus placebo brings about an improvement in attention and well-being and whether these changes are related to the improvement in the sleep structure.
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in continuity of sleep?
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in sleep architecture, especially an increase in deep sleep?
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning attentional performance?
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning well-being?
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged between 18 and 55 years
- •Normal sleeping times (at least 6 hours a night), going to sleep between 22.00 and 1.00 hours, getting up between 6.00 and 9.00 hours
- •Written informed consent
- •The volunteer is willing and able to cooperate fully
- •The volunteer agrees not to drink any alcohol for the duration of the study
排除标准
- •Participation in another study in the last 30 days or participation in this study at an earlier date
- •Lack of verbal or intellectual ability to communicate adequately and to understand the information to volunteers
- •Legal incompetence
- •Shift worker
- •Transatlantic flight in the last 4 weeks
- •Taking psychotropic drugs within the last 4 weeks
- •Taking medicines that influence the EEG within the last 4 weeks
- •Diseases that influence the sleep EEG
- •History of known medication / drug / alcohol misuse according to ICD-10 coding F10 - F19
- •Known intolerance/hypersensitivity/allergy to St. John's wort, valerian or passionflower
- •Taking inadmissible concomitant medication (anxiolytic, neuroleptic or hypnotic drugs, cyclosporin, sedative, sleep-promoting or mood-enhancing medicines, antidepressants other than the trial medication, coumarin-type anticoagulants, oral contraceptives, tranquillisers, homeopathic remedies, digoxin, theophylline, indinavir, nortriptyline, amitriptyline)
- •Known light-sensitivity
研究组 & 干预措施
Placebo
Placebo Comparator
Film-coated sugar-pill
干预措施: film-coated sugar-pill (Drug)
Verum
Experimental
Neurapas balance, film-coated tablets
干预措施: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)) (Drug)
结局指标
主要结局
Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)
时间窗: Day 3 + 14
次要结局
- Attention Stress Test d2 (Brickenkamp)(Day 4 + 15)
- Alertness and vigilance test (TAP)(Day 4 + 15)
- Trail-Making Test (TMT)(Day 4 + 15)
- Questionnaire on physical symptoms of subjective well-Being(MKSL, Janke)(Day 4 +15)
- Questionnaire on psychological aspects of well-being(BSKE, Janke)(Day 4 + 15)
- ZERSSEN Scale of evaluation of subjective well-being (Bf-S)(Day 4 + 15)
- Sleep Questionnaire(SF)(Day 4 + 15)
研究者
研究点 (1)
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