Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-01-01 @ 5:08 PM
Study NCT ID:
NCT02289235
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': 'C000713927', 'term': 'ginger extract'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-17', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2014-11-12', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ALT (liver transaminases) level', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in the concentration of ALT (liver transaminases)'}, {'measure': 'Change in score of fatty liver in fibroscan', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in score of fatty liver in fibroscan (elastography)'}], 'secondaryOutcomes': [{'measure': 'Change in AST (liver transaminases) level', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in the concentration of AST (liver transaminases)'}, {'measure': 'Change in Gama GT (γ-glutamyl transpeptidase) levels', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in the concentration of Gama GT (γ-glutamyl transpeptidase)'}, {'measure': 'Number of patients with adverse events', 'timeFrame': '4 months', 'description': 'Number of patients with adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ginger', 'Medicine, traditional', 'Herbal medicine'], 'conditions': ['Fatty Liver', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).', 'detailedDescription': "Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. It contains several hundred valuable compounds and new constituents are still being found. Ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner.\n\nIn a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Controlled type 2 diabetes mellitus (HbA1c\\<7%)\n* Age: 20-65 years\n* Body mass index: 18-35 kg/m2\n* Serum ALT level: \\>60 U/Lit. in males, \\>38 U/Lit. in females\n* Grade \\>=2 fatty liver in liver sonography\n\nExclusion Criteria:\n\n* Pregnancy\n* Acute or chronic liver failure\n* Acute or chronic renal failure\n* Autoimmune or viral hepatitis\n* Wilson's disease\n* Alcoholism\n* Malignancy\n* Hypothyroidism or hyperthyroidism\n* Drug used in last three months: OCP, vitamin E, ursodeoxycholic acid, glucocorticoids."}, 'identificationModule': {'nctId': 'NCT02289235', 'acronym': 'GinLivDM', 'briefTitle': 'Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'The Effects of Ginger on Biochemical Markers and Imaging Studies of Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease (NAFLD)', 'orgStudyIdInfo': {'id': 'CT-P-9364-6254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ginger', 'description': 'Ginger powder capsule 500 mg', 'interventionNames': ['Drug: Ginger']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo powder capsule', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ginger', 'type': 'DRUG', 'description': 'Ginger powder capsule 1000 mg twice daily for 3 months', 'armGroupLabels': ['Ginger']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo powder 2 capsules twice daily for 3 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Shahid Motahhari Clinic, Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'Mesbah Shams, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences'}, {'name': 'Majid Nimruzi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Traditional Medicine, Shiraz University of Medical Sciences'}, {'name': 'Kamran Bagheri Lankarani, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health policy Research Center, Shiraz University of Medical Sciences'}, {'name': 'Parisa-sadaat Ghoreishi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiraz University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Internal Medicine & Endocrinology', 'investigatorFullName': 'Mesbah Shams, MD', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}