Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep

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

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.

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?

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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