Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 4:31 PM
Study NCT ID:
NCT01178632
Status:
UNKNOWN
Last Update Posted:
2010-08-10
First Post:
2010-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of an Herbal Medicine on 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': 'C000713890', 'term': 'Valeriana extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-09', 'studyFirstSubmitDate': '2010-08-08', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton anxiety scale score', 'timeFrame': 'Four weeks', 'description': 'The primary outcome measure for effectiveness will be the score of the Hamilton Anxiety Scale (HAM-A). This scale will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.'}], 'secondaryOutcomes': [{'measure': 'Insomnia gravity index', 'timeFrame': 'Four weeks', 'description': 'The secondary outcome measure for effectiveness will be the score of the Insomnia gravity index. This questionnaire will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.'}, {'measure': 'Clinical global impression rate scale and Patient global evaluation rate scale', 'timeFrame': 'Four weeks', 'description': 'The other secondary outcome measure for effectiveness will be the clinical global impression rate scale and patient global evaluation rate scale. These scales will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Herbal', 'Phytotherapy', 'Passiflora', 'Valeriana', 'Anxiety'], 'conditions': ['Anxiety Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'ANXIETY DISORDERS'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'Passion Flower'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'Valeriana officinalis'}]}, 'descriptionModule': {'briefSummary': 'Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.', 'detailedDescription': 'The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.\n\nThe improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).\n\nDoes the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of generalized anxiety disorder\n* HAM-A scale \\> 17 and \\<30\n\nExclusion Criteria:\n\n* HAM-A scale \\> 30\n* Psychotherapy'}, 'identificationModule': {'nctId': 'NCT01178632', 'briefTitle': 'Therapeutic Effect of an Herbal Medicine on Anxiety', 'organization': {'class': 'INDUSTRY', 'fullName': 'Millet Roux'}, 'officialTitle': 'A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'MR4009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Passiflora, Anxiety Disorders', 'description': '1 tablet Passiflora;Crataegus;Salix; PO;BID', 'interventionNames': ['Drug: Passiflora']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valeriane, Anxiety Disorder', 'description': '1 tablet Valeriana officinalis, PO, BID', 'interventionNames': ['Drug: Valeriana officinalis']}], 'interventions': [{'name': 'Passiflora', 'type': 'DRUG', 'otherNames': ['PASSIFLORINE'], 'description': '01 tablet Passiflora p.o., b.i.d.', 'armGroupLabels': ['Passiflora, Anxiety Disorders']}, {'name': 'Valeriana officinalis', 'type': 'DRUG', 'otherNames': ['VALERIANE'], 'description': 'Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.', 'armGroupLabels': ['Valeriane, Anxiety Disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60430-270', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'contacts': [{'name': 'MARIA ELISABETE A MORAES, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ALEXANDRE AQUINO CAMARA, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinical Pharmacology Unit - Unifac', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}], 'centralContacts': [{'name': 'MARIA ELISABETE A MORAES, MD, PhD', 'role': 'CONTACT', 'email': 'betemora@matrix.com.br', 'phone': '5585-32232903'}], 'overallOfficials': [{'name': 'MARIA ELISABETE A MORAES, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CLINICAL PHARMACOLOGY UNIT - UNIFAC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millet Roux', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'FRANCISCO ALVES BORGES', 'oldOrganization': 'MILLET ROUX'}}}}