Clinical trial NCT00997256: Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Sleep Quality
Keywords: sleep-EEG
sleep architecture
sleep duration
sleep continuity
REM-sleep
vigilance
well-being
Healthy volunteers
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
First posted: 2009-10-19
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)
timeFrame: Day 3 + 14
Secondary outcomes:
measure: Attention Stress Test d2 (Brickenkamp)
timeFrame: Day 4 + 15
measure: Alertness and vigilance test (TAP)
timeFrame: Day 4 + 15
measure: Trail-Making Test (TMT)
timeFrame: Day 4 + 15
measure: Questionnaire on physical symptoms of subjective well-Being(MKSL, Janke)
timeFrame: Day 4 +15
measure: Questionnaire on psychological aspects of well-being(BSKE, Janke)
timeFrame: Day 4 + 15
measure: ZERSSEN Scale of evaluation of subjective well-being (Bf-S)
timeFrame: Day 4 + 15
measure: Sleep Questionnaire(SF)
timeFrame: Day 4 + 15
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Phillipps University, Clinic for Psychiatry and Psychotherapy
state: Hesse
Study officials:
affiliation: Phillipps University Marburg, Clinic for Psychiatry and Psychotherapy
name: Ulrich M Hemmeter, PD Dr Dr
role: PRINCIPAL_INVESTIGATOR
References: