Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-29 @ 12:03 PM
Study NCT ID:
NCT05570357
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2022-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Berberine and Cinnamon in Management of 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': 'C076628', 'term': 'tyramine-deoxysorbitol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-09', 'studyFirstSubmitDate': '2022-10-02', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1C', 'timeFrame': '0 and 12th week', 'description': 'HbA1C change from baseline'}], 'secondaryOutcomes': [{'measure': 'Fasting blood sugar', 'timeFrame': '0 and 12th week', 'description': 'Blood sugar change from baseline'}, {'measure': 'Lipid profile', 'timeFrame': '0 and 12th week', 'description': 'lipid profiles change from baseline'}, {'measure': 'Anthropometric measurements', 'timeFrame': '0 and 12th week', 'description': 'weight, height, BMI, WC'}, {'measure': 'Blood Pressure', 'timeFrame': '0 and 12th week', 'description': 'measuring according to the BP measurement guideline'}, {'measure': 'CRP', 'timeFrame': '0 and 12th week', 'description': 'measuring the blood concentration of C-reactive protein'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Berberine', 'Cinnamon'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'In this randomized clinical trial, patients with diabetes will be randomly assigned to receive either Berberine, and Cinnamon supplements or placebo for 12 weeks. Then the glycemic characteristics will be compared in two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-70 years\n* Diagnosed type-2 diabetes mellitus (based on American Diabetes Association criteria)\n\nExclusion Criteria:\n\n* Patients with an allergy to berberine /cinamon\n\n * Lactation, pregnancy\n * Patients with any malignancy\n * Patients with unrelated chronic illness\n * Patients with cardiac, liver or respiratory failure'}, 'identificationModule': {'nctId': 'NCT05570357', 'briefTitle': 'Berberine and Cinnamon in Management of Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'The Effects of Berberine and Cinnamon Supplementation on Diabetes Mangement', 'orgStudyIdInfo': {'id': '996401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'interventionNames': ['Dietary Supplement: Berberine+Cinnamon (TDS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo (TDS)']}], 'interventions': [{'name': 'Berberine+Cinnamon (TDS)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The supplements contains 400 mg Berberine, and 200 mg Cinnamon extract', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo (TDS)', 'type': 'OTHER', 'description': 'Placebo contains Maltodexterin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19835', 'city': 'Tehran', 'state': 'Middle East', 'country': 'Iran', 'facility': 'Azita Hekmatdoost', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}