Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-29 @ 4:07 AM
Study NCT ID:
NCT01145534
Status:
COMPLETED
Last Update Posted:
2011-11-09
First Post:
2010-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cissus Verticillata L. Infusion in Controlling Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005905', 'term': 'Glyburide'}], 'ancestors': [{'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood glucose', 'timeFrame': '60 days', 'description': 'Blood glucose was measured using a Gluco Dr. Plus (AGM-3000) Blood Glucose Monitoring System.'}], 'secondaryOutcomes': [{'measure': 'Salivary glucose level', 'timeFrame': '60 days', 'description': 'The level of glucose in saliva was measured in laboratory after colleting non-stimulated saliva in test tubes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes,', 'medicinal plants,', 'glucose'], 'conditions': ['Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ccs.ufpb.br/gefao/', 'label': 'Official research group for studies related to medicinal plants'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of type 2 Diabetes patients.', 'detailedDescription': 'Type 2 diabetes mellitus is regarded as one of the most prevalent disease of the adult population. In many developing countries, this condition is regarded as major public health problem. Type 2 diabetes is a metabolic disorder characterized by high blood glucose related with a condition of insulin resistance and relative insulin deficiency. As Diabetes progresses, medications are necessary to control glucose levels.\n\nThe aim of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be as effective as a regular drug (glibenclamide) in reducing glucose levels in blood and saliva of type 2 Diabetes patients. Several medicinal plants have been used as potential medication for controlling glucose levels in Diabetes patients. Few studies have explored this effect related to Cissus verticillata L.infusion, though it has been indicated by folk medicine of some Latin American countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects of 30 up to 80 years of age\n* positive diagnostic for type 2 diabetes mellitus (blood glucose level above 126 mg/dL)\n* patients that signed the informed consent\n\nExclusion Criteria:\n\n* patients with renal and hepatic disfunction,\n* patients with cardiac problems or other systemic alterations (allergies, pulmonary and gastrointestinal problems)\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT01145534', 'briefTitle': 'Evaluation of Cissus Verticillata L. Infusion in Controlling Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Paraíba'}, 'officialTitle': 'Phase 1 Study for Testing Efficacy of Cissus Verticillata L Infusion in Controlling Glucose Concentration', 'orgStudyIdInfo': {'id': 'UFPB-0346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glibenclamide', 'description': 'Patients used 5 mg glibenclamide daily for 60 days', 'interventionNames': ['Drug: glibenclamide']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Patients ingested the infusion of Cissus verticillata L. prepared as 1 g in 150 mL of hot water for 10 min. This was done daily for 60 days', 'interventionNames': ['Other: medicinal plant infusion']}], 'interventions': [{'name': 'glibenclamide', 'type': 'DRUG', 'otherNames': ['Glibenclamida, Legrand GE'], 'description': '5 mg as pills, taken daily during the morning for 60 days', 'armGroupLabels': ['Glibenclamide']}, {'name': 'medicinal plant infusion', 'type': 'OTHER', 'otherNames': ['popular plant name: Insulina'], 'description': 'INfusion fo Cissus verticillata L., 1 g in 150 mL water, ingested daily for 60 days.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58700-020', 'city': 'Patos', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Centro de Especialidades Odontologicas', 'geoPoint': {'lat': -7.02444, 'lon': -37.28}}], 'overallOfficials': [{'name': 'Fabio C Sampaio, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University fo Paraiba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Paraíba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Rosana Araújo Rosendo', 'oldOrganization': 'Federal University of Paraiba'}}}}