NCT00997256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
Last Updated

May 17, 2010

Status Verified

May 1, 2010

Enrollment Period

1 month

First QC Date

October 16, 2009

Last Update Submit

May 14, 2010

Conditions

HealthySleep Quality

Keywords

sleep-EEGsleep architecturesleep durationsleep continuityREM-sleepvigilancewell-beingHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)

    Day 3 + 14

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Verum

EXPERIMENTAL

Neurapas balance, film-coated tablets

Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))

Placebo

PLACEBO COMPARATOR

Film-coated sugar-pill

Drug: film-coated sugar-pill

Interventions

Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))DRUG

3 x 2 tablets / day over 3 days

Also known as: Neurapas balance, film-coated tablet over 3 days
Verum
film-coated sugar-pillDRUG

3 x 2 tablets / day over 3 days

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phillipps University, Clinic for Psychiatry and Psychotherapy

Marburg, Hesse, 35039, Germany

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Valeriana extract

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Ulrich M Hemmeter, PD Dr Dr

    Phillipps University Marburg, Clinic for Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 19, 2009

Study Start

December 1, 2004

Primary Completion

January 1, 2005

Study Completion

February 1, 2005

Last Updated

May 17, 2010

Record last verified: 2010-05

Locations

DE(1)