Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-04-15 @ 1:47 PM
Study NCT ID:
NCT02326766
Status:
COMPLETED
Last Update Posted:
2014-12-29
First Post:
2014-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058246', 'term': 'Prehypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-26', 'studyFirstSubmitDate': '2014-12-22', 'studyFirstSubmitQcDate': '2014-12-26', 'lastUpdatePostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes from baselilne in blood pressure', 'timeFrame': '12 week'}], 'secondaryOutcomes': [{'measure': 'changes from baseline in plasma metabolites', 'timeFrame': '12 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prehypertension']}, 'referencesModule': {'references': [{'pmid': '26843120', 'type': 'DERIVED', 'citation': 'Cha TW, Kim M, Kim M, Chae JS, Lee JH. Blood pressure-lowering effect of Korean red ginseng associated with decreased circulating Lp-PLA2 activity and lysophosphatidylcholines and increased dihydrobiopterin level in prehypertensive subjects. Hypertens Res. 2016 Jun;39(6):449-56. doi: 10.1038/hr.2016.7. Epub 2016 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting plasma metabolomes.', 'detailedDescription': 'A randomized, double-blind, placebo-controlled study was conducted on nonobese, nondiabetic and prehypertensive subjects. Over a 12 week test period, the red ginseng group (n=31) consumed 10 capsules (total 5g) daily containing red ginseng, while the placebo group (n=31) consumed the same product without red ginseng. Fasting plasma metabolomes were profiled using UPLC-LTQ-Orbitrap mass spectrometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nondiabetic, nonobese and prehypertensive subjects with blood pressures ranging 120 - 139 mmHg (systolic) or 80-89 mmHg (diastolic) were enrolled in this study.\n\nExclusion Criteria:\n\n* exclusion criteria included previous diagnosed clinical hypertension\n* self-reported use of antihypertensive medication\n* abnormal liver or renal function\n* history of cardiovascular disease\n* kidney disease\n* cancer\n* thyroid or pituitary disease or any other serious life-threatening illness that required regular medical treatment\n* we also excluded women who were pregnant, breast feeding or intending to become pregnant during the time of study.'}, 'identificationModule': {'nctId': 'NCT02326766', 'briefTitle': 'Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': 'KGC_metabolites_14121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KRG', 'description': '5g Korea red ginseng (KRG)', 'interventionNames': ['Dietary Supplement: KRG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '5 g placebo (corn starch)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'KRG', 'type': 'DIETARY_SUPPLEMENT', 'description': '5g Korea red ginseng (KRG)', 'armGroupLabels': ['KRG']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '5g placebo', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}