Status:
COMPLETED
Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep
Lead Sponsor:
Pascoe Pharmazeutische Praeparate GmbH
Conditions:
Healthy
Sleep Quality
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00997256
Start Date
December 1 2004
End Date
February 1 2005
Last Update
May 17 2010
Active Locations (1)
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1
Phillipps University, Clinic for Psychiatry and Psychotherapy
Marburg, Hesse, Germany, 35039