Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 12:38 PM
Study NCT ID:
NCT00754832
Status:
COMPLETED
Last Update Posted:
2012-01-24
First Post:
2008-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
American Ginseng Treatment for Multiple Sclerosis Related Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cameromi@ohsu.edu', 'phone': '503-418-1971', 'title': 'Dr. Michelle Cameron', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ginseng', 'description': 'ginseng 100 mg daily escalating to 400 mg daily for 6 weeks', 'otherNumAtRisk': 56, 'otherNumAffected': 5, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo 1 tab daily escalating to 4 tabs daily for 6 weeks', 'otherNumAtRisk': 56, 'otherNumAffected': 4, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'flu like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fatigue Severity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ginseng', 'description': 'ginseng 100 mg daily escalating to 400 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo 1 tab daily escalating to 4 tabs daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 6 weeks of intervention', 'description': 'The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Modified Fatigue Impact Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ginseng', 'description': 'ginseng 100 mg daily escalating to 400 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo 1 tab daily escalating to 4 tabs daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '43.7', 'spread': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks of intervention', 'description': '21 item scale, score range 0-84, lower scores indicate less fatigue', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Realtime Digital Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ginseng', 'description': 'ginseng 100 mg daily escalating to 400 mg daily for 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo 1 tab daily escalating to 4 tabs daily for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks of intervention', 'description': 'fatigue scored on 0-10 scale with higher scores indicating more fatigue', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ginseng First Then Placebo', 'description': 'ginseng 100 mg daily escalating to 400 mg daily for 6 weeks followed by 2 weeks washout, then placebo 1 cap daily escalating to 4 caps daily for 6 weeks'}, {'id': 'FG001', 'title': 'Placebo First Then Ginseng', 'description': 'placebo 1 cap daily escalating to 4 caps daily for 6 weeks followed by 2 weeks washout, then ginseng 100 mg daily escalating to 400 mg daily for 6 weeks'}], 'periods': [{'title': 'First 6 Weeks Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': '2 Weeks Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Second 6 Weeks Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intent to Treat Study Population', 'description': 'all participants who received at least one dose of either placebo or ginseng in this crossover trial'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-20', 'studyFirstSubmitDate': '2008-09-16', 'resultsFirstSubmitDate': '2011-09-09', 'studyFirstSubmitQcDate': '2008-09-17', 'lastUpdatePostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-20', 'studyFirstPostDateStruct': {'date': '2008-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Severity Scale', 'timeFrame': 'after 6 weeks of intervention', 'description': 'The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.'}], 'secondaryOutcomes': [{'measure': 'Modified Fatigue Impact Scale', 'timeFrame': '6 weeks of intervention', 'description': '21 item scale, score range 0-84, lower scores indicate less fatigue'}, {'measure': 'Realtime Digital Fatigue Score', 'timeFrame': '6 weeks of intervention', 'description': 'fatigue scored on 0-10 scale with higher scores indicating more fatigue'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'fatigue', 'ginseng'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '21803872', 'type': 'RESULT', 'citation': 'Kim E, Cameron M, Lovera J, Schaben L, Bourdette D, Whitham R. American ginseng does not improve fatigue in multiple sclerosis: a single center randomized double-blind placebo-controlled crossover pilot study. Mult Scler. 2011 Dec;17(12):1523-6. doi: 10.1177/1352458511412062. Epub 2011 Jul 29.'}, {'pmid': '20803391', 'type': 'DERIVED', 'citation': 'Kim E, Lovera J, Schaben L, Melara J, Bourdette D, Whitham R. Novel method for measurement of fatigue in multiple sclerosis: Real-Time Digital Fatigue Score. J Rehabil Res Dev. 2010;47(5):477-84. doi: 10.1682/jrrd.2009.09.0151.'}]}, 'descriptionModule': {'briefSummary': 'This research project will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment of MS fatigue.', 'detailedDescription': 'Fatigue is a major cause of disability in MS and is associated with a reduced quality of life. Treatment options for MS fatigue include central nervous system stimulants and amantadine. These medications are of limited efficacy, are often poorly tolerated, and can be expensive. Ginseng may represent a novel approach to treating MS fatigue. Ginseng has been tested in clinical trials for its ability to improve mental alertness and fatigue. However, there have been no published clinical trials addressing the effects of ginseng in subjects with MS, even though many people with MS use ginseng and report deriving benefit from it.\n\nThis double-blinded, placebo controlled crossover pilot study will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs. placebo for the treatment of MS fatigue. Additionally, the project will collect information on the impact of ginseng on cognition, stress, actigraphy, salivary cortisol, differential cytokine response, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MS as diagnosed by the McDonald criteria\n* Complaint of fatigue that has been persistent for at least 2 months\n* FSS score of 4 or greater;\n* Age 18-70.\n\nExclusion Criteria:\n\n* Use of ginseng or stimulants in the prior 6 weeks\n* Acute treatment with glucocorticoids in the prior 6 weeks\n* BDI \\>31\n* Significant MS exacerbation in prior 30 days\n* Diabetes\n* Uncontrolled hypertension\n* Other serious medical disease, pregnancy or breastfeeding\n* Breast disease\n* Abnormal bleeding or clotting disorder\n* Current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline, isocarboxazid, or phenelzine\n* Current use of lasix for poorly controlled hypertension or congestive heart failure\n* Current drug or alcohol abuse; inability to complete the self report forms'}, 'identificationModule': {'nctId': 'NCT00754832', 'briefTitle': 'American Ginseng Treatment for Multiple Sclerosis Related Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue', 'orgStudyIdInfo': {'id': '1357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo', 'interventionNames': ['Drug: American ginseng extract HT-1001', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention', 'interventionNames': ['Drug: American ginseng extract HT-1001', 'Drug: placebo']}], 'interventions': [{'name': 'American ginseng extract HT-1001', 'type': 'DRUG', 'description': 'Ginseng HT-1001 was dosed at 100 mg orally per day initially, increased after one week to 200 mg per day, then further increased the next week to 400 mg per day as tolerated. Subjects were then maintained on 400 mg per day or the maximum tolerated dose for the remainder of the 6 week treatment period.', 'armGroupLabels': ['1', '2']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['placebo (matched capsules to ginseng drug)'], 'description': 'Placebo capsules were identical to the study drug and were dose escalated to match the study drug. Subjects were maintained on placebo capsules for the remainder of the 6 week treatment period.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Ruth Whitham, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Multiple Sclerosis Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Ruth Whitham', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}