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/Schlafstörunge

• Conditions: volunteers with non-organic slight insomnia (DSM IIII R primary insomnia).

• Registration Number: EUCTR2005-001031-29-DE
• Lead Sponsor: Bioforce GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified