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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Neurapas balance, film-coated tablets |
|
| Placebo | Placebo Comparator | Film-coated sugar-pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)) | Drug | 3 x 2 tablets / day over 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture) | Day 3 + 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Attention Stress Test d2 (Brickenkamp) | Day 4 + 15 | |
| Alertness and vigilance test (TAP) | Day 4 + 15 | |
| Trail-Making Test (TMT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich M Hemmeter, PD Dr Dr | Phillipps University Marburg, Clinic for Psychiatry and Psychotherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phillipps University, Clinic for Psychiatry and Psychotherapy | Marburg | Hesse | 35039 | Germany |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000713890 | Valeriana extract |
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| film-coated sugar-pill | Drug | 3 x 2 tablets / day over 3 days |
|
| 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 |
| D001523 |
| Mental Disorders |