Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-28 @ 10:38 PM
Study NCT ID:
NCT00794456
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2008-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C007145', 'term': 'crataegus extract'}, {'id': 'C000713809', 'term': 'willow bark extract'}, {'id': 'C000713890', 'term': 'Valeriana extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2008-11-19', 'studyFirstSubmitQcDate': '2008-11-19', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton anxiety scale', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Insomnia gravity index; global clinical impression; patients global evaluation', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Passiflora', 'Crataegus', 'Herbal', 'Valeriana', 'anxiety'], 'conditions': ['Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'Phase III, multicentric, double blind, randomized study, controlled by Valeriana officinalis for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. on mild and moderate anxiety. The treatment period will last 6 weeks and be followed by a post treatment visit.\n\nHamilton anxiety scale will be used to assess anxiety.', 'detailedDescription': 'Passiflora incarnata L; Crataegus Oxyacantha L are plant-derived treatment widely used to treat anxiety disorders. This study will compare the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L for the treatment of mild and moderate anxiety. 150 participants will be randomly assigned to receive the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. or Valeriana officinalis for 6 weeks. A post treatment visit will be done 2 weeks for safety evaluation.\n\nPrimary outcome: Hamilton anxiety (HAM-A) scale Secondary outcome: Insomnia quality index, Global clinical impression and patients global evaluation scales.\n\nSide effects will be monitorized throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* generalized anxiety disorder\n* HAM-A scale \\< 17 and \\> 30\n\nExclusion Criteria:\n\n* hypersensibility to any component\n* patients with depression, schizophrenia ou suicidal ideas\n* pregnant ou lactating\n* heart, liver, lung or kidney important condition\n* use of digitalis, AAS, anticoagulants agents, drugs with sedative or antidepressant action\n* psychotherapy\n* drug or alcohol dependence\n* gastrointestinal ulcer history\n* hyperthyroidism\n* neoplasia\n* coagulation disorders'}, 'identificationModule': {'nctId': 'NCT00794456', 'briefTitle': 'Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety', 'organization': {'class': 'INDUSTRY', 'fullName': 'Marjan Industria e Comercio ltda'}, 'officialTitle': 'Double Blind, Randomized Study, Controlled by Valeriana Officinalis, of Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Patients With Mild and Moderate Anxiety', 'orgStudyIdInfo': {'id': 'MJ 3002-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.', 'interventionNames': ['Drug: Passiflora ; Crataegus and Salix']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Valeriana officinalis 50 mg', 'interventionNames': ['Drug: Valeriana']}], 'interventions': [{'name': 'Passiflora ; Crataegus and Salix', 'type': 'DRUG', 'otherNames': ['Pasalix'], 'description': '1 tablet PO twice a day', 'armGroupLabels': ['1']}, {'name': 'Valeriana', 'type': 'DRUG', 'otherNames': ['Valeriana officinalis 50 mg'], 'description': '1 tablet PO twice a day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60430-270', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Unidade de Farmacologia Clínica - UNIFAC', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '04024-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Maria Elisabete A Moraes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Ceará'}, {'name': 'Antonio C Lopes, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Sao Paulo - UNIFESP / DPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marjan Industria e Comercio ltda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}