Wirkung einer einmaligen Einnahme eines alkoholischen Baldrian/Hopfen Flüssigextraktes (Dormeasan® -Tropfen) im Vergleich zu Placebo auf das Schlafverhalten von Patienten mit Ein- bzw. Durchschlafstörungen.(Effects of a single-dose intake of an alcoholic liquid extract Valerian/Hops (Dormeasan drops) in comparison to placebo on the sleep of patients with slight sleep disturbances). - Baldrian/Hopfen/Schlafstörungen

Bioforce GmbH0 个研究点目标入组 40 人开始时间: 2005年4月21日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•* both sexes,
•* age between 30 and 70 years (each inclusive),
•* only slight sleep disturbance with inconspicuous history and clinical findings,
•*objective findings - during polysomnographic recording - of sleep disturbances (total sleep time < 6,5h and/or sleep efficiency (related to total bed time) < 83% and/or sleep latency (up to reaching the sleeping stage II) > 30min and/or percentage of toatl awaking time >10% realted to total bed time],
•* negative finding of alcohol at the time of screening-investigation and at the evening of test night,
•* written informed consent to participate at the study (informed consent).
•* protection to get pregnant in woman in childbearing ages.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•* clinical relevant acute or chronical diseases,
•* clinical relevant sleep disturbances need to be treated (e.g. sleep apnea,
•parasomnia),
•* clinical relevant pathological findings from clinical or laboratoty results,
•* clinical pathological EEG-findings,
•* clinical relevant Allergies,
•* drug or alcohol abuse,
•* positive finding of alcohol at Screening-investigation,
•* clinical relevant drugs taken in in the last 3 days before the first test night (visit1),
•and during active study phase,
•* clinical relevant drugs to be taken continuously,
•* body weight < 50 kg und > 115 kg,
•* abuse of coffee, tee or tobacco,
•/smoking within 2 h before arrival at the trial centre and start of the
•polysomnographic recording (PSG).
•/coffein 4 h before arrival at the trial centre and start of the PSG.
•/alcohol 24 h before arrival at the trial centre and start of the PSG.
•* missing written informed consent,
•* participation in another clinical study within 60 days before start of the study.
•* pregnancy or breastfeeding period.

发起方

Bioforce GmbH