Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-25 @ 4:36 PM
Study NCT ID:
NCT03775733
Status:
UNKNOWN
Last Update Posted:
2020-05-08
First Post:
2018-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2018-12-12', 'studyFirstSubmitQcDate': '2018-12-12', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of blood glucose', 'timeFrame': '12 weeks', 'description': 'Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.'}], 'secondaryOutcomes': [{'measure': 'Changes of blood insulin', 'timeFrame': '12 weeks', 'description': 'Changes of blood insulin during OGTT were assessed before and after the intervention.'}, {'measure': 'Changes of area under the curve of Glucose and Insulin', 'timeFrame': '12 weeks', 'description': 'Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention.'}, {'measure': 'Changes of Homeostatic model assessment-insulin resistance', 'timeFrame': '12 weeks', 'description': 'Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention.'}, {'measure': 'Changes of Homeostatic model assessment-beta-cell', 'timeFrame': '12 weeks', 'description': 'Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention'}, {'measure': 'Changes of HbA1c', 'timeFrame': '12 weeks', 'description': 'Changes of HbA1c(%) were assessed before and after the intervention'}, {'measure': 'Changes of C-peptide', 'timeFrame': '12 weeks', 'description': 'Changes of C-peptide(ng/ml) were assessed before and after the intervention.'}, {'measure': 'Changes of lipid profile', 'timeFrame': '12 weeks', 'description': 'Changes of lipid profile were assessed before and after the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydrolysed red ginseng extract', 'Glucose', 'Clinical Trial'], 'conditions': ['Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.', 'detailedDescription': 'This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Hydrolysed Red Ginseng extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 19-80 years with fasting glucose 100-140 mg/dL\n\nExclusion Criteria:\n\n* Weight less than 48 kg or weight decreased by more than 10% within past 3 months\n* Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.\n* Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months\n* Blood sugar improvement or healthy functional food within past 1 month\n* Under antipsychotic medication therapy within past 2 months\n* History of alcohol or substance abuse\n* Participation in any other clinical trials within past 2 months\n* Laboratory test by show the following results\n\n * aspartate aminotransferase, alanine aminotransferase \\> Reference range 3 times upper limit\n * Serum Creatinine \\> 2.0 mg/dl\n* Pregnancy or breast feeding\n* If a woman of childbearing doesn't accept the implementation of appropriate contraception\n* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc."}, 'identificationModule': {'nctId': 'NCT03775733', 'briefTitle': 'Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate The Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia', 'orgStudyIdInfo': {'id': 'GH-HG-HR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrolysed red ginseng extract', 'description': 'Hydrolysed red ginseng extract 2.4g/day for 12 weeks', 'interventionNames': ['Dietary Supplement: Hydrolysed Red Ginseng Extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for 12 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Hydrolysed Red Ginseng Extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.', 'armGroupLabels': ['Hydrolysed red ginseng extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo for 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soo-Wan Chae, MD., PhD', 'role': 'CONTACT', 'email': 'swchae@jbctc.org', 'phone': '82-63-259-3040'}], 'facility': 'Clinical Trial Center for Functional Foods Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Trial Center for Functional Foods', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}