Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep
NCT ID: NCT00997256
Last Updated: 2010-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2004-12-31
2005-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of the Herbal Medicine Sominex ® (Passiflora Incarnata L., Valeriana Officinalis L. and Crataegus Oxyacantha L.), Manufactured by the Laboratory EMS S / A in Patients With Psychophysiological Insomnia
NCT01100645
PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases
NCT01125605
Efficacy and Safety of Valerian Root Extract and Lavender Essential Oil Combination, Over 4 Weeks in Subjects With Sleep Complaints
NCT05194618
Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
NCT01376869
Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
NCT04812418
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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?
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Verum
Neurapas balance, film-coated tablets
Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))
3 x 2 tablets / day over 3 days
Placebo
Film-coated sugar-pill
film-coated sugar-pill
3 x 2 tablets / day over 3 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))
3 x 2 tablets / day over 3 days
film-coated sugar-pill
3 x 2 tablets / day over 3 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
55 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pascoe Pharmazeutische Praeparate GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pascoe Pharmazeutische Preparate GmbH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ulrich M Hemmeter, PD Dr Dr
Role: PRINCIPAL_INVESTIGATOR
Phillipps University Marburg, Clinic for Psychiatry and Psychotherapy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phillipps University, Clinic for Psychiatry and Psychotherapy
Marburg, Hesse, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PSC 152/04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.