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

Phase 1

Completed

• Conditions: Healthy; Sleep Quality
• Interventions: Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)); 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?

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2005-01
• Study Completion: 2005-02
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-14
• Last Update Posted: 2010-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

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