Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep (sleep-EEG)

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Sleep Quality
• Intervention / Treatment: Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)); Drug: film-coated sugar-pill

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hesse
    • Marburg, Hesse, Germany, 35039
      • Phillipps University, Clinic for Psychiatry and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum; Neurapas balance, film-coated tablets	Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)); 3 x 2 tablets / day over 3 days; Other Names: Neurapas balance, film-coated tablet over 3 days
Placebo Comparator: Placebo; Film-coated sugar-pill	Drug: film-coated sugar-pill; 3 x 2 tablets / day over 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)	Day 3 + 14

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pascoe Pharmazeutische Praeparate GmbH
• Investigators: Principal Investigator: Ulrich M Hemmeter, PD Dr Dr, Phillipps University Marburg, Clinic for Psychiatry and Psychotherapy

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): January 1, 2005
• Study Completion (Actual): February 1, 2005

Study Registration Dates

• First Submitted: October 16, 2009
• First Submitted That Met QC Criteria: October 16, 2009
• First Posted (Estimate): October 19, 2009

Study Record Updates

• Last Update Posted (Estimate): May 17, 2010
• Last Update Submitted That Met QC Criteria: May 14, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Healthy volunteers; well-being; sleep architecture; sleep duration; vigilance; sleep-EEG; sleep continuity; REM-sleep
• Other Study ID Numbers: PSC 152/04