Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-29 @ 3:47 AM
Study NCT ID:
NCT00781534
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2008-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Ginseng in 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': 'C000713447', 'term': 'Asian ginseng'}, {'id': 'C049864', 'term': 'ginsenoside Re'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2008-10-27', 'studyFirstSubmitQcDate': '2008-10-27', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health Supplements', 'Ginseng', 'Diabetes'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '21411505', 'type': 'DERIVED', 'citation': 'Reeds DN, Patterson BW, Okunade A, Holloszy JO, Polonsky KS, Klein S. Ginseng and ginsenoside Re do not improve beta-cell function or insulin sensitivity in overweight and obese subjects with impaired glucose tolerance or diabetes. Diabetes Care. 2011 May;34(5):1071-6. doi: 10.2337/dc10-2299. Epub 2011 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'a clinical study of Ginseng its potential affect on diabetes', 'detailedDescription': 'Comparing three groups (those with \\& without normal blood sugar levels) to see if there is any clinically significant change in blood sugar levels in relationship to those taking:\n\n1. ginseng\n2. ginsenoside RE (a type of metabolized ginseng)\n3. placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 18-65\n* healthy, non-diabetic\n* healthy, impaired glucose tolerance/mild diabetes (no medications required)\n\nExclusion Criteria:\n\n* impaired glucose tolerance (borderline diabetes that requires medications)\n* diabetes (requiring medications)\n* caffeine sensitivity\n* known cardiac, peripheral vascular diseases\n* arrhythmias (irregular heart rhythms)'}, 'identificationModule': {'nctId': 'NCT00781534', 'briefTitle': 'A Clinical Trial of Ginseng in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Clinical Trial of Ginseng for Glucose Intolerance', 'orgStudyIdInfo': {'id': '03-0824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. Ginseng', 'description': 'Ginseng group', 'interventionNames': ['Drug: Ginseng']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Ginsenosdie RE', 'description': 'Ginsenoside RE (a metabolite of ginseng) group', 'interventionNames': ['Drug: Ginseng', 'Drug: ginsenoside RE']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3. Placebo', 'description': 'placebo ("sugar" pill) group', 'interventionNames': ['Dietary Supplement: Placebo (sugar pill)']}], 'interventions': [{'name': 'Ginseng', 'type': 'DRUG', 'description': 'Each of the 3 arms will be compared to determine if there is any clinical difference in blood sugars between the 3 groups', 'armGroupLabels': ['1. Ginseng']}, {'name': 'Ginseng', 'type': 'DRUG', 'armGroupLabels': ['2. Ginsenosdie RE']}, {'name': 'ginsenoside RE', 'type': 'DRUG', 'description': 'active metabolite of ginseng', 'armGroupLabels': ['2. Ginsenosdie RE']}, {'name': 'Placebo (sugar pill)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'placebo group', 'armGroupLabels': ['3. Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Kenneth S Polonsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kenneth S. Polonsky, MD', 'oldOrganization': 'Washington University School of Medicine'}}}}