Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-27 @ 4:29 PM
Study NCT ID:
NCT00944268
Status:
UNKNOWN
Last Update Posted:
2009-07-24
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-23', 'studyFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2009-07-22', 'lastUpdatePostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Scales', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Safety evaluation by adverse events relate.', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Passiflora, Crataegus and Salix', 'Mild and Moderate anxiety', 'Tablet', 'To evaluate the efficacy and tolerability of the combination'], 'conditions': ['Anxiety', 'Efficacy', 'Tolerability']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L, Crataegus oxyacantha and Salix alba L in mild and moderate anxiety.\n\nClinical study phase III, multicenter, prospective, open.\n\nPatients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who achieve scores between 18 and 29 points in the Hamilton Scale for Anxiety;\n* Individuals of any ethnic group male and female, aged above 18 years;\n* Consent of the subject of research (a consent form signed).\n\nExclusion Criteria:\n\n* Patients with known hypersensitivity to any components of the formula;\n* Pregnant women and nursing mothers;\n* Patients with endogenous depression, schizophrenia, suicidal tendency;\n* Patients with heart disease unabated, unabated kidney, liver and lung unabated unabated, at the discretion of the investigator;\n* Addiction to drugs, including alcohol, at the discretion of the investigator;\n* Patients who are using any medication that could interfere with the effect of the drug under study;\n* Impossibility of compliance to the protocol'}, 'identificationModule': {'nctId': 'NCT00944268', 'acronym': 'E01ATCAL0308', 'briefTitle': 'Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ativus Farmaceutica Ltda'}, 'officialTitle': 'Clinical Study Phase III, Multicenter, Prospective, Open to Evaluate the Efficacy and Tolerability of the Combination Use of Passiflora Incarnata L, Crataegus Oxyacantha and Salix Alba L in Mild and Moderate Anxiety', 'orgStudyIdInfo': {'id': 'E01-AT-CAL-03-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liquid and solid', 'interventionNames': ['Drug: Passiflora, Crataegus e Salix']}], 'interventions': [{'name': 'Passiflora, Crataegus e Salix', 'type': 'DRUG', 'description': 'Comparison of different pharmaceutics forms of drug', 'armGroupLabels': ['Liquid and solid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09060650', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Elie Fiss', 'role': 'CONTACT', 'email': 'eliefiss@uol.com.br', 'phone': '55 1149935469'}, {'name': 'Elie Fiss', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculdade de Medicina do ABC', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}], 'centralContacts': [{'name': 'Dagoberto Brandão', 'role': 'CONTACT', 'email': 'dagoberto@phcbrasil.com.br', 'phone': '55 11 36733763'}], 'overallOfficials': [{'name': 'Elie Fiss', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Medicina do ABC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ativus Farmaceutica Ltda', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Olinto Mascarenhas Marques', 'oldOrganization': 'ATIVUS FARMACÊUTICA LTDA'}}}}