Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep
- Conditions
- HealthySleep Quality
- Interventions
- Drug: film-coated sugar-pill
- Registration Number
- NCT00997256
- Lead Sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Brief Summary
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.
- Detailed Description
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.
1. 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?
2. 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?
3. 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?
4. 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?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- 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
- 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
- Smoker
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Verum Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)) Neurapas balance, film-coated tablets Placebo film-coated sugar-pill Film-coated sugar-pill
- Primary Outcome Measures
Name Time Method Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture) Day 3 + 14
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Phillipps University, Clinic for Psychiatry and Psychotherapy
🇩🇪Marburg, Hesse, Germany