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

This study has been completed.
Sponsor:
Information provided by:
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT00997256
First received: October 16, 2009
Last updated: May 14, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
Sleep Quality
 Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))
Drug: film-coated sugar-pill
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:
  • Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture) [ Time Frame: Day 3 + 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Attention Stress Test d2 (Brickenkamp) [ Time Frame: Day 4 + 15 ] [ Designated as safety issue: No ]
  • Alertness and vigilance test (TAP) [ Time Frame: Day 4 + 15 ] [ Designated as safety issue: No ]
  • Trail-Making Test (TMT) [ Time Frame: Day 4 + 15 ] [ Designated as safety issue: No ]
  • Questionnaire on physical symptoms of subjective well-Being(MKSL, Janke) [ Time Frame: Day 4 +15 ] [ Designated as safety issue: No ]
  • Questionnaire on psychological aspects of well-being(BSKE, Janke) [ Time Frame: Day 4 + 15 ] [ Designated as safety issue: No ]
  • ZERSSEN Scale of evaluation of subjective well-being (Bf-S) [ Time Frame: Day 4 + 15 ] [ Designated as safety issue: No ]
  • Sleep Questionnaire(SF) [ Time Frame: Day 4 + 15 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2004
Study Completion Date: February 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum
Neurapas balance, film-coated tablets
 Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))
3 x 2 tablets / day over 3 days
Other Name: 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
Other Name: 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?
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997256

Locations
Germany
Phillipps University, Clinic for Psychiatry and Psychotherapy
Marburg, Hesse, Germany, 35039
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Investigators
Principal Investigator: Ulrich M Hemmeter, PD Dr Dr Phillipps University Marburg, Clinic for Psychiatry and Psychotherapy
  More Information

No publications provided

Responsible Party: Anja Braschoss, Pascoe Pharmazeutische Preparate GmbH
ClinicalTrials.gov Identifier: NCT00997256     History of Changes
Other Study ID Numbers: PSC 152/04
Study First Received: October 16, 2009
Last Updated: May 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
sleep-EEG
sleep architecture
sleep duration
sleep continuity
 REM-sleep
vigilance
well-being
Healthy volunteers

ClinicalTrials.gov processed this record on May 23, 2013