Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-02-21 @ 10:05 AM
Study NCT ID:
NCT00860795
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2009-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunologic Effects of Echinacea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718679', 'term': 'Echinacea extract'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uncjat@u.washington.edu', 'phone': '206-616-1206', 'title': 'James A Taylor, MD', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days', 'otherNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days', 'otherNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'gas/indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'taste: abnormal/metallic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'urinary: difficult/painful', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'weakness/fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}, {'term': 'other', 'notes': 'tongue tingling, tongue numbness, lip numbness reported by 3 participants taking Echinacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MOSES'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2694', 'spread': '1299', 'groupId': 'OG000'}, {'value': '2648', 'spread': '1625', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.17', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'tumor necrosis factor alpha NK cells and evidence of CD25/69 activation', 'unitOfMeasure': 'tumor necrosis alpha level (pg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Maximal Levels of Interferon Alpha (pg/ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '47', 'groupId': 'OG000'}, {'value': '35', 'spread': '69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.72', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.', 'unitOfMeasure': 'interferon alpha level (pg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Maximal CD25/69 Activation (% of NK CD25/69+ Cells)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '.70', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.2', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation', 'unitOfMeasure': '(% of NK CD25/69+ cells)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days'}], 'classes': [{'title': 'constipation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'blurred vision', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'diarrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'gas/indigestion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'nausea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'taste: abnormal/metallic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'musculoskeletal pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'fever', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'sore throat', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'nasal congestion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'rash', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'anxiety', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'insomnia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'weakness/fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'urinary: difficult/painful', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'participants', 'denomUnitsSelected': 'participants', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Maximal Levels of Interleukin 2 (pg/ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '287', 'spread': '244', 'groupId': 'OG000'}, {'value': '829', 'spread': '1072', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.51', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.', 'unitOfMeasure': 'interleukin 2 level (pg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Maximal Levels of Interleukin 6 (pg/ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5085', 'spread': '375', 'groupId': 'OG000'}, {'value': '2862', 'spread': '8761', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.43', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.', 'unitOfMeasure': 'interleukin 6 level (pg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Maximal Levels of Interleukin 12 (pg/ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '17', 'groupId': 'OG000'}, {'value': '6', 'spread': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.61', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.', 'unitOfMeasure': 'interleukin 12 level (pg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'id': 'FG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Number to Complete Study Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One participant discontinued study medication on day 5, but completed safety evaluations', 'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy adults were recruited using general advertising and enrolled between March and August 2009'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Echinacea', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'id': 'BG001', 'title': 'Placebo', 'description': '25 ml daily in 2 divided doses for 10 days'}, {'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', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '37.4', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '36.5', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-29', 'studyFirstSubmitDate': '2009-03-10', 'resultsFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2009-03-11', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-10-20', 'studyFirstPostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)', 'timeFrame': '10 days', 'description': 'tumor necrosis factor alpha NK cells and evidence of CD25/69 activation'}], 'secondaryOutcomes': [{'measure': 'Maximal Levels of Interferon Alpha (pg/ml)', 'timeFrame': '10 days', 'description': 'interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.'}, {'measure': 'Maximal CD25/69 Activation (% of NK CD25/69+ Cells)', 'timeFrame': '10 days', 'description': 'NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation'}, {'measure': 'Adverse Effects', 'timeFrame': '30 days'}, {'measure': 'Maximal Levels of Interleukin 2 (pg/ml)', 'timeFrame': '10 days', 'description': 'interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.'}, {'measure': 'Maximal Levels of Interleukin 6 (pg/ml)', 'timeFrame': '10 days', 'description': 'interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.'}, {'measure': 'Maximal Levels of Interleukin 12 (pg/ml)', 'timeFrame': '10 days', 'description': 'interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Echinacea', 'prevention', 'immune modulation'], 'conditions': ['Upper Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medication and after completing the course of medication. It is postulated that adults receiving the Echinacea will have evidence of immune stimulation and those receiving placebo will not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults 21-65 years old\n* If female of child-bearing potential, willing to use contraception to prevent pregnancy\n* Speaks and reads English\n* No use of any medication (other than multivitamins, essential fatty acids or probiotics)\n* Willing to abstain from ingesting edible mushrooms throughout study\n* Willing to eat less than 2 garlic cloves per day throughout study\n\nExclusion Criteria:\n\n* Positive pregnancy test or currently breastfeeding\n* History of autoimmune disease\n* History of allergic rhinitis\n* History of physician diagnosed eczema\n* Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago) and sunflower (Helianthus)\n* Use of any medication within 30 days prior to first dose of study medication that is a known inhibitor or inducer of CYP34A'}, 'identificationModule': {'nctId': 'NCT00860795', 'briefTitle': 'Immunologic Effects of Echinacea', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Study of the Immunologic Effects of Echinacea Purpurea in Adults', 'orgStudyIdInfo': {'id': '09A1236'}, 'secondaryIdInfos': [{'id': '5U01AT002400', 'link': 'https://reporter.nih.gov/quickSearch/5U01AT002400', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Echinacea', 'interventionNames': ['Biological: Echinacea purpurea']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Echinacea purpurea', 'type': 'BIOLOGICAL', 'description': 'Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days', 'armGroupLabels': ['Echinacea']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo 25 ml daily in 2 divided doses for 10 days', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98028', 'city': 'Kenmore', 'state': 'Washington', 'country': 'United States', 'facility': 'Bastyr University', 'geoPoint': {'lat': 47.75732, 'lon': -122.24401}}], 'overallOfficials': [{'name': 'James A Taylor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'School of Medicine: Pediatrics', 'investigatorFullName': 'James Taylor', 'investigatorAffiliation': 'University of Washington'}}}}