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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014