Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-30 @ 6:22 AM
Study NCT ID:
NCT00911768
Status:
COMPLETED
Last Update Posted:
2009-08-06
First Post:
2009-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Korean Red Ginseng (KRG) on Dry Mouth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pjw2907@khu.ac.kr', 'phone': '+082-02-440-6219', 'title': 'Jae-Woo Park, KMD, PhD', 'organization': 'Kyung Hee East-West Neo Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Korean Red Ginseng', 'description': 'Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.'}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.'}]}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analogue Scale of Subjective Dry Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Korean Red Ginseng', 'description': 'Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.21', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '5.03', 'spread': '1.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.181', 'ciLowerLimit': '-0.647', 'ciUpperLimit': '1.008', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.416', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because primay outcome of the study was changes of Visual Analogue Scale of Subjective Dry Mouth between 0, 4 and 8 weeks, per protocol analysis was applied.'}, {'type': 'SECONDARY', 'title': 'Stimulated Salivary Flow Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Korean Red Ginseng', 'description': 'Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.046', 'spread': '0.552', 'groupId': 'OG000'}, {'value': '1.392', 'spread': '0.549', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.346', 'ciLowerLimit': '-0.576', 'ciUpperLimit': '-0.115', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A non-inferiority analysis was conducted. We just compared the difference of stimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.', 'unitOfMeasure': 'ml/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because secondary outcome of the study was also changes of stimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.', 'anticipatedPostingDate': '2009-06'}, {'type': 'SECONDARY', 'title': 'Unstimulated Salivary Flow Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Korean Red Ginseng', 'description': 'Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.220', 'spread': '0.153', 'groupId': 'OG000'}, {'value': '0.266', 'spread': '0.185', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.086', 'ciLowerLimit': '-0.155', 'ciUpperLimit': '-0.017', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A non-inferiority analysis was conducted. We just compared the difference of unstimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.', 'unitOfMeasure': 'ml/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because secondary outcome of the study was changes of unstimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.', 'anticipatedPostingDate': '2009-04'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Korean Red Ginseng', 'description': 'Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from the waiting room and consulting room of Oriental Clinic of Gastrointestinal diseases and Chronic fatigue of Kyung Hee East-West Neo-Medical Center (Seoul, Korea) between September 2007 and February 2008', 'preAssignmentDetails': 'Totally, 133 participants were enrolled in the trial; 100 participants screened and 33 of them (women 18, men 15) were excluded because of abnormal liver function (1), present illness (2), a plan to pregnancy (1), and self refusals or disconnections (28).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Korean Red Ginseng', 'description': 'Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0.0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89.0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.14', 'spread': '15.97', 'groupId': 'BG000'}, {'value': '46.02', 'spread': '16.14', 'groupId': 'BG001'}, {'value': '47.1', 'spread': '16.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54.0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100.0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-03', 'studyFirstSubmitDate': '2009-03-03', 'resultsFirstSubmitDate': '2009-03-03', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-07', 'studyFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale of Subjective Dry Mouth', 'timeFrame': '8 weeks', 'description': 'Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.'}], 'secondaryOutcomes': [{'measure': 'Stimulated Salivary Flow Rates', 'timeFrame': '8 weeks', 'description': 'Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.'}, {'measure': 'Unstimulated Salivary Flow Rates', 'timeFrame': '8 weeks', 'description': 'Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Xerostomia', 'Panax ginseng(Korean Red Ginseng)', 'Visual Analogue Scale', 'Salivary Flow Rates'], 'conditions': ['Xerostomia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).', 'detailedDescription': 'Korean Red Ginseng\n\n* Worldwide use\n* A main herb of old oriental prescriptions for dry mouth\n* Need for correct information by RCT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dry mouth patients\n\nExclusion Criteria:\n\n* Sjögren syndrome\n* Irradiation related xerostomia\n* Severe psychiatric diseases\n* pregnancy or breast feeding women'}, 'identificationModule': {'nctId': 'NCT00911768', 'briefTitle': 'Effect of Korean Red Ginseng (KRG) on Dry Mouth', 'organization': {'class': 'OTHER', 'fullName': 'The Korean Society of Ginseng'}, 'officialTitle': 'PMS Clinical Study of Korean Red Ginseng Powder on Dry Mouth and Salivary Flow Rates in Xerostomatic Populations', 'orgStudyIdInfo': {'id': 'KHNMC-OH-IRB 2007-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Korean Red Ginseng group', 'description': "The brand name of experimental drug is 'Capsule of Korean Red Ginseng Powder'. It consists of the powder of steamed root of Panax ginseng made by Korean Ginseng Corp.", 'interventionNames': ['Dietary Supplement: Korean Red Ginseng Powder Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Corn-starch powder with ginseng flavor', 'description': 'The placebo of this study is corn-starch powder with Korean Red Ginseng flavor. It has the same shape, color and flavor like experimental drug.', 'interventionNames': ['Dietary Supplement: Corn-starch powder with ginseng flavor']}], 'interventions': [{'name': 'Korean Red Ginseng Powder Capsule', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Brand Name: Korean Red Ginseng Powder Capsule'], 'description': 'Generic name: Korean Red Ginseng Powder Capsule Original herb name: Panax ginseng Form and contents: Capsule with powder of steamed root of 6-year Panax ginseng Dosage and frequency: 6 g per day (twice a day), Oral administration Administration duration: 56 days in the study', 'armGroupLabels': ['Korean Red Ginseng group']}, {'name': 'Corn-starch powder with ginseng flavor', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Corn-starch powder capsule with Korean Red Ginseng flavor'], 'description': 'There is no specific name because this intervention is placebo. This placebo has the same form, color and flavor as Korean Red Ginseng Powder Capsule.\n\nThe dosage form, dosage, frequency and duration is also same as experimental intervention (Korean Red Ginseng Powder Capsule).\n\nMain contents: corn-starch with Panax ginseng flavor', 'armGroupLabels': ['Corn-starch powder with ginseng flavor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '134-090', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee East-West Neo Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Woo Park, K.M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee East-West Neo Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Korean Society of Ginseng', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jae-Woo Park, KMD, PhD', 'oldOrganization': 'Kyung Hee East-West Neo Medical Center'}}}}