Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-25 @ 10:18 AM
Study NCT ID:
NCT01634256
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Human Trial to Evaluate the Efficacy and Safety of Fermented Turmeric in Subjects Showing Mild Hepatic Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clickm@jbnu.ac.kr', 'phone': '82-63-276-8284', 'title': 'Dr. Sang-Wook Kim, MD', 'organization': 'Clinical Trial Center for Functional Foods; Chonbuk National University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Serious and/or other \\[non-serious\\] adverse events were not collected/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Fermented Curcuma', 'description': 'Oral intake fermented curcuma (3.0g/day) for 12weeks.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Oral intake placebo(3.0g/day) for 12weeks', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in ALT(Alanine Transaminase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fermented Turmeric', 'description': 'Oral intake Fermented turmeric (3.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(3.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '61.08', 'spread': '25.10', 'groupId': 'OG000'}, {'value': '55.68', 'spread': '15.09', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '44.92', 'spread': '15.47', 'groupId': 'OG000'}, {'value': '53.82', 'spread': '26.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'ALT was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Changes in AST(Aspartate Transaminase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fermented Turmeric', 'description': 'Oral intake Fermented turmeric (3.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(3.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '36.27', 'spread': '13.80', 'groupId': 'OG000'}, {'value': '35.59', 'spread': '8.82', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '27.96', 'spread': '7.96', 'groupId': 'OG000'}, {'value': '34.77', 'spread': '10.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'AST was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Changes in ALP(Alkaline Phosphatase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fermented Turmeric', 'description': 'Oral intake Fermented turmeric (3.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(3.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '85.04', 'spread': '19.33', 'groupId': 'OG000'}, {'value': '71.73', 'spread': '13.47', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '80.04', 'spread': '21.98', 'groupId': 'OG000'}, {'value': '68.95', 'spread': '13.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'ALP was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Changes in γ-GT(Gamma-Glutamyl Transferase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fermented Turmeric', 'description': 'Oral intake Fermented turmeric (3.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(3.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '86.31', 'spread': '71.49', 'groupId': 'OG000'}, {'value': '104.2', 'spread': '69.00', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '66.96', 'spread': '45.63', 'groupId': 'OG000'}, {'value': '100.77', 'spread': '68.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'γ-GT was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Changes in Serum Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fermented Turmeric', 'description': 'Oral intake Fermented turmeric (3.0g/day) for 12weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral intake placebo(3.0g/day) for 12weeks'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fermented Turmeric', 'description': 'Fermented turmeric(3times/day, 6capsules/day, 3g/day) for 12weeks\n\nFermented curcuma : Powdered Curcuma longa L., was produced through the fermentation of Aspergillus oryzae to 25 ˚ C for 36 hours.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo(3times/day, 6capsules/day, 3g/day) for 12weeks\n\nPlacebo : Amount and calorie of placebo are same with Fermented turmeric.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.', 'preAssignmentDetails': 'The criteria were an age from 19 to 70 years, ALT levels ≥ 40IU/L subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fermented Curcuma'}, {'id': 'BG001', 'title': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.03', 'spread': '8.53', 'groupId': 'BG000'}, {'value': '36.17', 'spread': '7.42', 'groupId': 'BG001'}, {'value': '37.60', 'spread': '8.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2012-07-03', 'resultsFirstSubmitDate': '2012-07-11', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-04', 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in ALT(Alanine Transaminase)', 'timeFrame': '12 weeks', 'description': 'ALT was measured in study visit 1(0 week) and visit 3(12 week).'}], 'secondaryOutcomes': [{'measure': 'Changes in AST(Aspartate Transaminase)', 'timeFrame': '12 weeks', 'description': 'AST was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in ALP(Alkaline Phosphatase)', 'timeFrame': '12 weeks', 'description': 'ALP was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in γ-GT(Gamma-Glutamyl Transferase)', 'timeFrame': '12 weeks', 'description': 'γ-GT was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in Serum Bilirubin', 'timeFrame': '12 weeks', 'description': 'serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mild Hepatic Injury']}, 'referencesModule': {'references': [{'pmid': '23497020', 'type': 'DERIVED', 'citation': 'Kim SW, Ha KC, Choi EK, Jung SY, Kim MG, Kwon DY, Yang HJ, Kim MJ, Kang HJ, Back HI, Kim SY, Park SH, Baek HY, Kim YJ, Lee JY, Chae SW. The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: a randomised controlled study. BMC Complement Altern Med. 2013 Mar 8;13:58. doi: 10.1186/1472-6882-13-58.'}]}, 'descriptionModule': {'briefSummary': 'The investigators performed a double-blind parallel study in a group of showing mild hepatic injury subjects who were given Fermented turmeric over a period of 12 weeks. The investigators measured liver function parameters , including ALT(Alanine Transaminase), AST(Aspartate Transaminase), ALP(Alkaline Phosphatase), γ-GT(Gamma-Glutamyl Transferase), and serum bilirubin, and monitored their blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females 19-70 years old\n* Mild hepatic injury as indicated by ALT(Alanine Transaminase) level ≥ 40\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to any of the ingredients in the test products\n* History of reaction to any of the experimental products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery\n* Carriers of viral hepatitis (type B and C)\n* History of underlying Esophageal varices, hepatic encephalopathy, ascites(past 12 months)\n* Participation in other clinical trials within the past 2 months\n* Patients with acute hepatitis (type B and C)\n* History of underlying cirrhosis and liver cancer\n* History of underlying biliary diseases such as jaundice or gallstones\n* History of underlying kidney disease such as Chronic renal failure or nephrotic syndrome\n* Pregnant, planning to become pregnant, or breast-feeding\n* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study"}, 'identificationModule': {'nctId': 'NCT01634256', 'briefTitle': 'A Human Trial to Evaluate the Efficacy and Safety of Fermented Turmeric in Subjects Showing Mild Hepatic Injury', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'orgStudyIdInfo': {'id': 'INs-LF-CURCUMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fermented turmeric', 'interventionNames': ['Dietary Supplement: Fermented turmeric']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo(3.0g/day)', 'armGroupLabels': ['Placebo']}, {'name': 'Fermented turmeric', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fermented turmeric(3.0g/day)', 'armGroupLabels': ['Fermented turmeric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560-822', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Clinical Trial Center for Functional Foods; Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'overallOfficials': [{'name': 'Sang-Wook Kim, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Trial Center for Functional Foods', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}