Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-24 @ 11:22 PM
Study NCT ID:
NCT01542905
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2012-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress Relief Effect of Korean Red Ginseng
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713447', 'term': 'Asian ginseng'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-23', 'studyFirstSubmitDate': '2012-02-26', 'studyFirstSubmitQcDate': '2012-02-26', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Stress Scores at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks'}, {'measure': 'Change from Baseline in Stress Scores at 4 Weeks', 'timeFrame': 'Baseline and 4 Weeks'}, {'measure': 'Change from Baseline in Stress Scores at 1 Week', 'timeFrame': 'Baseline and 1 Week'}, {'measure': 'Change from Baseline in Neurocognitive Function at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks'}, {'measure': 'Change from Baseline in Brain Function, Chemistry, and Structure Measured Using Magnetic Resonance Imaging at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Fatigue Scores at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks'}, {'measure': 'Change in Fatigue Scores at 4 Weeks', 'timeFrame': 'Baseline and 4 Weeks'}, {'measure': 'Change in Fatigue Scores at 1 Week', 'timeFrame': 'Baseline and 1 Week'}, {'measure': 'Change in Depressive Scores at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks'}, {'measure': 'Change in Depressive Scores at 4 Weeks', 'timeFrame': 'Baseline and 4 Weeks'}, {'measure': 'Change in Depressive Scores at 1 Week', 'timeFrame': 'Baseline and 1 Week'}, {'measure': 'Change in Anxiety Scores at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks'}, {'measure': 'Change in Anxiety Scores at 4 Weeks', 'timeFrame': 'Baseline and 4 Weeks'}, {'measure': 'Change in Anxiety Scores at 1 Week', 'timeFrame': 'Baseline and 1 Week'}, {'measure': 'Number of Participants Who Experienced Adverse Events', 'timeFrame': 'Week 1'}, {'measure': 'Number of Participants Who Experienced Adverse Events', 'timeFrame': 'Week 4'}, {'measure': 'Number of Participants Who Experienced Adverse Events', 'timeFrame': 'Week 8'}]}, 'conditionsModule': {'conditions': ['Stress Relief']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine clinical and neuropsychiatric effects of Korean Red Ginseng and examine changes in brain structure, function and metabolites. A total of 60 healthy volunteers will be recruited and will be assigned to either Korean Red Ginseng group or placebo group. Individuals will be examined through clinical assessment, neuropsychological function tests and neuroimaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages between 18\\~65\n\nExclusion Criteria:\n\n* Current or past medical history, medical illnesses that are detected during clinical and physical evaluations\n* Current Axis 1 diagnosis or past history of schizophrenia, bipolar, or psychotic disorders assessed by SCID-IV\n* Current diagnosis of substance abuse assessed by SCID-IV\n* Taking or have taken psychiatric medication in the past 2 months\n* Head trauma accompanied by loss of consciousness or seizure\n* IQ 80 or below\n* Planning pregnancy, currently pregnant, or breastfeeding\n* Claustrophobia or other fMRI incompatible factors such as pace makers\n* Taking drugs, including over the counter drugs'}, 'identificationModule': {'nctId': 'NCT01542905', 'briefTitle': 'Stress Relief Effect of Korean Red Ginseng', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effects of Korean Red Ginseng on Stress Relief and Cognitive and Mental Function Enhancement Using Neuroimaging: Double-Blind, Randomized, Placebo-Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'KG2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Korean Red Ginseng', 'interventionNames': ['Dietary Supplement: Korean Red Ginseng']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Korean Red Ginseng', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Korean Red Ginseng Capsule (1g/day) for 8 Weeks', 'armGroupLabels': ['Korean Red Ginseng']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo Capsule (1g/day) for 8 Weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In Kyoon Lyoo, MD, PhD, MMS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'In Kyoon Lyoo, MD, PhD, MMS', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}