Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-29 @ 11:16 PM
Study NCT ID:
NCT00997256
Status:
COMPLETED
Last Update Posted:
2010-05-17
First Post:
2009-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713890', 'term': 'Valeriana extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-14', 'studyFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2010-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)', 'timeFrame': 'Day 3 + 14'}], 'secondaryOutcomes': [{'measure': 'Attention Stress Test d2 (Brickenkamp)', 'timeFrame': 'Day 4 + 15'}, {'measure': 'Alertness and vigilance test (TAP)', 'timeFrame': 'Day 4 + 15'}, {'measure': 'Trail-Making Test (TMT)', 'timeFrame': 'Day 4 + 15'}, {'measure': 'Questionnaire on physical symptoms of subjective well-Being(MKSL, Janke)', 'timeFrame': 'Day 4 +15'}, {'measure': 'Questionnaire on psychological aspects of well-being(BSKE, Janke)', 'timeFrame': 'Day 4 + 15'}, {'measure': 'ZERSSEN Scale of evaluation of subjective well-being (Bf-S)', 'timeFrame': 'Day 4 + 15'}, {'measure': 'Sleep Questionnaire(SF)', 'timeFrame': 'Day 4 + 15'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sleep-EEG', 'sleep architecture', 'sleep duration', 'sleep continuity', 'REM-sleep', 'vigilance', 'well-being', 'Healthy volunteers'], 'conditions': ['Healthy', 'Sleep Quality']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\n1. 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?\n2. 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?\n3. 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?\n4. 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?'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male volunteers aged between 18 and 55 years\n* 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\n* Written informed consent\n* The volunteer is willing and able to cooperate fully\n* The volunteer agrees not to drink any alcohol for the duration of the study\n\nExclusion Criteria:\n\n* Participation in another study in the last 30 days or participation in this study at an earlier date\n* Lack of verbal or intellectual ability to communicate adequately and to understand the information to volunteers\n* Legal incompetence\n* Smoker\n* Shift worker\n* Transatlantic flight in the last 4 weeks\n* Taking psychotropic drugs within the last 4 weeks\n* Taking medicines that influence the EEG within the last 4 weeks\n* Diseases that influence the sleep EEG\n* History of known medication / drug / alcohol misuse according to ICD-10 coding F10 - F19\n* Known intolerance/hypersensitivity/allergy to St. John's wort, valerian or passionflower\n* 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)\n* Known light-sensitivity"}, 'identificationModule': {'nctId': 'NCT00997256', 'acronym': 'sleep-EEG', 'briefTitle': 'Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pascoe Pharmazeutische Praeparate GmbH'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PSC 152/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum', 'description': 'Neurapas balance, film-coated tablets', 'interventionNames': ['Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Film-coated sugar-pill', 'interventionNames': ['Drug: film-coated sugar-pill']}], 'interventions': [{'name': 'Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))', 'type': 'DRUG', 'otherNames': ['Neurapas balance, film-coated tablet over 3 days'], 'description': '3 x 2 tablets / day over 3 days', 'armGroupLabels': ['Verum']}, {'name': 'film-coated sugar-pill', 'type': 'DRUG', 'description': '3 x 2 tablets / day over 3 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35039', 'city': 'Marburg', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Phillipps University, Clinic for Psychiatry and Psychotherapy', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'overallOfficials': [{'name': 'Ulrich M Hemmeter, PD Dr Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Phillipps University Marburg, Clinic for Psychiatry and Psychotherapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pascoe Pharmazeutische Praeparate GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Anja Braschoss', 'oldOrganization': 'Pascoe Pharmazeutische Preparate GmbH'}}}}