Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-03 @ 11:52 PM
Study NCT ID:
NCT00563004
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2007-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of DBcare, a Food Supplement on Diabetes Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-27', 'studyFirstSubmitDate': '2007-11-22', 'studyFirstSubmitQcDate': '2007-11-23', 'lastUpdatePostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of more than 0.5% GBA1C in the treatment group compared to placebo', 'timeFrame': '3 months'}, {'measure': 'Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Herbal treatment', 'Food supplement'], 'conditions': ['Diabetes Mellitus, Non-insulin Dependant', 'Diabetes Mellitus Type 2', 'Diabetes Mellitus, on Oral Hypoglycemic Treatment', 'Adult Type Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'DBcare is a herbal food supplement that has been used over the years in India as a "traditional"anti-diabetic formula.DBcare was not tested controlled trials in humans, yet.We intend to test the ability of DBCare to improve blood sugar level control in patients with uncontrolled diabetes.', 'detailedDescription': 'Study design: prospective, randomized, single-blind, placebo-controlled trial\n\nInclusion criteria:\n\nMen and women (older than 18 years old) with type 2 diabetes and inadequate glycemic control, defined by HbA1C 8% ³ £10%.\n\nPrevious medications include any oral hypoglycemic agents, as monotherapy or in combination.\n\nConcurrent lipid-lowering, anti-hypertensive and other medications are allowed\n\nExclusion criteria (before the study):\n\nType 1 diabetes mellitus Pregnant or lactating women Insulin treatment 3 months prior to study entry Creatinine \\>2 mg/dL Abnormal liver function tests GOT\\>X2 or GPT\\>X2 the upper normal limit Unstable anginal syndrome Congestive heart failure (NYHA class I-IV) Inability to follow study instructions including low compliance\n\nExclusion criteria (during the study):\n\nSevere hypoglycemia (less than 50 mg%) or any hypoglycemic event requiring intravenous glucose infusion\n\nNumber of patients: 30 patients (drug) 30 patients (placebo)\n\nDesign:\n\nFour out-patient visits, at enrollment and every month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn On the 2nd 3rd and 4th visits pill-count will be performed Glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the morning, on a daily basis\n\nDrugs: identical drug containing/ placebo capsules Drugs for a month will be given in each monthly visit\n\nDose: 2 tablets three times daily'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>18y\n* With type 2 diabetes mellitus and inadequate glycemic control\n* HBA1C \\>8 \\<10\n* Previous medications include oral hypoglycemic medications,as monotherapy or in combination\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Pregnant or lactating women\n* Insulin treatment 3 months prior to study entry\n* Creatinine \\>2\n* Abnormal liver function test GOT\\>2 or GPT\\>2 the upper limit of norm\n* Unstable anginal syndrome\n* Congestive heart failure NYHA 1-4\n* Inability to follow study instructions'}, 'identificationModule': {'nctId': 'NCT00563004', 'briefTitle': 'The Effect of DBcare, a Food Supplement on Diabetes Control', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'A Double-blind Placebo Controlled Study Studying the Efficacy of DBCARE in Improving Diabetes Control', 'orgStudyIdInfo': {'id': 'DBcare1'}, 'secondaryIdInfos': [{'id': 'DBCARE01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Patients receive the herbal medication DBCARE for 3 months', 'interventionNames': ['Dietary Supplement: DBCARE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'PATIENTS RECEIVE PLACEBO PILLS', 'interventionNames': ['Dietary Supplement: DBCARE']}], 'interventions': [{'name': 'DBCARE', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients receive dbcare 2 tablets TID for 3 months', 'armGroupLabels': ['A']}, {'name': 'DBCARE', 'type': 'DIETARY_SUPPLEMENT', 'description': 'PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'overallOfficials': [{'name': 'Pnina ROTMAN-PIKELNY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR', 'investigatorFullName': 'pninarotman', 'investigatorAffiliation': 'Meir Medical Center'}}}}