Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-20 @ 4:43 PM
Study NCT ID:
NCT04120259
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2019-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D008687', 'term': 'Metformin'}, {'id': 'D019342', 'term': 'Acetic Acid'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-17', 'studyFirstSubmitDate': '2019-10-07', 'studyFirstSubmitQcDate': '2019-10-07', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI (Anthropometric Measurement)', 'timeFrame': '12 weeks', 'description': 'Body Mass Index: A measure of obesity calculated as weight in kilograms divided by height in meters square'}, {'measure': 'Measurement of Hemoglobin A1c', 'timeFrame': '12 weeks', 'description': 'A blood test for Glycated Hemoglobin that represents a 2-3 month glycemic control'}, {'measure': 'Measurement of Fasting Blood Sugar', 'timeFrame': '12 weeks', 'description': 'A blood test that involves the measurement of plasma glucose after 8 to 12 hours of fasting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': "'This study aims to compare the effect of Metformin alone vs Metformin plus Apple Cider Vinegar in newly diagnosed Type 2 Diabetic Patients", 'detailedDescription': 'Diabetes Mellitus is one of the oldest diseases known to men and has been treated with multiple agents,organic and with the current pharmacological advancement,with multiple synthetic drugs as well.\n\nMetformin has been considered first line for the treatment of Type 2 Diabetes, however presents itself with a side effect profile of GI distress, Vitamin B12 deficiency,to name a few.\n\nVinegar has been used as therapeutic agent for centuries for multiple ailments including diabetes. This study aims to evaluate the combined effects of drug and natural therapy and compare it with conventional therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recently diagnosed Type 2 diabetic patients taking metformin 750 mg daily as the oral antidiabetic agent\n* Patients with Hemoglobin A1c in the range of 6.5 to 7.5%\n\nExclusion Criteria:\n\n* All newly diagnosed Diabetic Patients requiring a dosage other than 750 mg per day\n* Patients on Insulin Therapy or any drugs for diabetes other than Metformin\n* Pregnant and Lactating women\n* Patients with food allergies to either apple or any source of vinegar\n* Patients unable to communicate efficiently\\\\mentally challenged\n* Type 2 Diabetic patients with any of the complications of long standing uncontrolled diabetes'}, 'identificationModule': {'nctId': 'NCT04120259', 'briefTitle': 'Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics:A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Intervention: Metformin Tablet oral 750 mg OD', 'interventionNames': ['Drug: Metformin Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Intervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD', 'interventionNames': ['Drug: Metformin Oral Tablet', 'Dietary Supplement: Vinegar']}], 'interventions': [{'name': 'Metformin Oral Tablet', 'type': 'DRUG', 'description': 'A biguanide drug used as a first line therapy for Diabetes MellitusType 2', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Vinegar', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A common herbal/dietary supplement used for centuries as an anti bacterial, cleaning,cooking, anti diabetic agent, to name a few uses.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Ziauddin University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Dr Momina Abid, MBBS,M Phil (ongoing)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University'}, {'name': 'Dr Zahida Memon, MBBS,M Phil,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziauddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Momina Abid', 'investigatorFullName': 'Dr Momina Abid', 'investigatorAffiliation': 'Ziauddin University'}}}}