Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-26 @ 1:54 AM
Study NCT ID:
NCT01734005
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2012-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Red Ginseng on Decrement of Body Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713447', 'term': 'Asian ginseng'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], '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': '2012-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-25', 'studyFirstSubmitDate': '2012-11-21', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Body Fat Mass', 'timeFrame': '12 weeks', 'description': 'Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in Percent Body Fat', 'timeFrame': '12 weeks', 'description': 'Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).'}], 'secondaryOutcomes': [{'measure': 'Changes in weight', 'timeFrame': '12 weeks', 'description': 'Weight was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in BMI(body mass index)', 'timeFrame': '12 weeks', 'description': 'BMI(body mass index) was measured in study visit 1(0 week) and visit 3(12 week).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of red ginseng on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females 19-65 years old\n* BMI(body mass index) ≥ 25 kg/m\\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Significant variation in weight(more 10%) in the past 3 months\n* Allergic or hypersensitive to any of the ingredients in the test products\n* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery\n* History of alcohol or substance abuse\n* Participation in any other clinical trials within past 2 months\n* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study\n* Pregnant or lactating women etc."}, 'identificationModule': {'nctId': 'NCT01734005', 'briefTitle': 'Efficacy and Safety of Red Ginseng on Decrement of Body Fat', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'orgStudyIdInfo': {'id': 'ARIMED-BF-GC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Red Ginseng', 'interventionNames': ['Dietary Supplement: Red Ginseng']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Red Ginseng', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Red Ginseng (1.4g/day)', 'armGroupLabels': ['Red Ginseng']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (1.4g/day)', 'armGroupLabels': ['Placebo']}]}, '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}}]}, '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'}}}}