Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 10:06 AM
Study NCT ID:
NCT00587860
Status:
COMPLETED
Last Update Posted:
2010-03-09
First Post:
2007-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C422326', 'term': 'Hypericum extract LI 160'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'saito.yuri@mayo.edu', 'phone': '507-284-5010', 'title': 'Yuri A. Saito Loftus, M.D., M.P.H.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '* A majority of the participants were local females with mild symptoms\n* The number of participants limits power of conclusions\n* We evaluated the efficacy of SJW in all subtypes of IBS not allowing specific conclusions regarding subtypes'}}, 'adverseEventsModule': {'timeFrame': 'Study duration', 'description': 'Patients will be evaluated on a bi-weekly basis by phone interview and paper questionnaire. During these queries, subjects will be asked to report study medication compliance and side effects or adverse events (AE). Adverse events will be categorized into Serious Adverse Events (SAE) and Non-serious Adverse Events (NAE).', 'eventGroups': [{'id': 'EG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day", 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo, twice a day', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Bowel Symptom Scores (BSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '165'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '125'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After 12 weeks of treatment', 'description': 'The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks).\n\nThe BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is \\~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.'}, {'type': 'SECONDARY', 'title': 'Bowel Symptom Score (BSS) Amongst Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}], 'classes': [{'title': 'BSS for diarrhea subgroup', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '92'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '94'}]}]}, {'title': 'BSS for constipation subgroup', 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '78'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '84'}]}]}, {'title': 'BSS for pain subgroup', 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '77'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '77'}]}]}, {'title': 'BSS for bloating subgroup', 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '75'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is \\~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.'}, {'type': 'SECONDARY', 'title': 'Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last 4 weeks of therapy', 'description': 'Participants who reported "yes" or "no" to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '69.8'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks of treatment', 'description': 'The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Center for Epidemiologic Studies Depression Scale (CES-D) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IBS Symptoms Moderately or a Lot Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Center for Epidemiologic Studies Depression Scale (CES-D) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 weeks', 'description': 'We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bowel Symptom Score (BSS) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '149'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '152'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 weeks', 'description': 'The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were identified through community, institutional advertisement, clinicaltrials.gov, through the IFFGD webpage as well as through the outpatient clinics beginning in February 2006. Participants who participated in previous IBS studies were also mailed a recruitment letter to ask if they would be interested in participating.', 'preAssignmentDetails': 'For this study, there was a 2-week screening and enrollment phase. During this period, participants were screened, a symptom questionnaire was completed, and there was a physician exam. After the in-person screening visit, a phone call was made prior to mailing the study materials to ensure the participant was still willing to participate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "St. John's Wort", 'description': "St. John's Wort, 450 mg twice a day"}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo, twice a day'}, {'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': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '14.34', 'groupId': 'BG000'}, {'value': '39.43', 'spread': '11.26', 'groupId': 'BG001'}, {'value': '40.81', 'spread': '12.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Bowel Symptom Score (BSS)', 'classes': [{'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '314'}, {'value': '165', 'groupId': 'BG001', 'lowerLimit': '73', 'upperLimit': '290'}, {'value': '169', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '314'}]}]}], 'paramType': 'MEDIAN', 'description': 'The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Center for Epidemiologic Studies Depression Scale (CES-D) score', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '5.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'description': 'We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Irritable Bowel Syndrome - Quality of Life (IBS-QoL)', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '62'}, {'value': '20', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '79'}, {'value': '21.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'description': 'The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-02', 'studyFirstSubmitDate': '2007-12-27', 'resultsFirstSubmitDate': '2009-10-26', 'studyFirstSubmitQcDate': '2008-01-07', 'lastUpdatePostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-12', 'studyFirstPostDateStruct': {'date': '2008-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Bowel Symptom Scores (BSS)', 'timeFrame': 'After 12 weeks of treatment', 'description': 'The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks).\n\nThe BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.'}], 'secondaryOutcomes': [{'measure': 'Bowel Symptom Score (BSS) Amongst Subgroups', 'timeFrame': '12 weeks', 'description': 'Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.'}, {'measure': 'Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy', 'timeFrame': 'Last 4 weeks of therapy', 'description': 'Participants who reported "yes" or "no" to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy.'}, {'measure': 'Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score', 'timeFrame': '12 weeks of treatment', 'description': 'The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.'}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D) Score', 'timeFrame': '12 weeks', 'description': 'We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.'}, {'measure': 'IBS Symptoms Moderately or a Lot Better', 'timeFrame': '24 weeks', 'description': 'Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks.'}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D) Score', 'timeFrame': '24 weeks', 'description': 'We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.'}, {'measure': 'Bowel Symptom Score (BSS) at 24 Weeks', 'timeFrame': '24 weeks', 'description': 'The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is being done to see if St. John\'s wort helps people with irritable bowel syndrome, otherwise known as "IBS". St. John\'s wort is a herbal supplement derived from the St. John\'s wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes.', 'detailedDescription': 'Eligibility criteria:\n\n1. Established diagnosis of IBS\n2. 18-70 years of age\n\n4\\) U.S. resident 5) English-speaking (able to provide consent and complete questionnaires) 6) Able to participate in all aspects of the study\n\nYou will be asked to do the following:\n\n* Undergo a screening interview and physical examination\n* Take a urine pregnancy test (if applicable)\n* Take a study pill twice daily for 12 weeks(3 months)\n* Complete daily symptom diaries and bi-weekly questionnaires for 12 weeks.\n* Complete a questionnaire at 6 months after the active phase of the study is over.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Established diagnosis of IBS\n* Meet Rome II diagnostic criteria for IBS\n* 18-70 years of age\n* U.S. resident\n* English-speaking (able to provide consent and complete questionnaires)\n* Able to participate in all aspects of the study\n\nExclusion Criteria:\n\n* Known alternative/concurrent gastrointestinal diagnosis (e.g. Crohn's disease, ulcerative colitis, microscopic colitis, celiac sprue, chronic pancreatitis or pancreatic insufficiency, scleroderma, chronic intestinal pseudo-obstruction, bacterial overgrowth, recent (\\<6 months) intestinal bacterial/protozoal/ parasitic infections, HIV, fecal incontinence, small bowel or colonic resection, pelvic floor dysfunction, paraplegia or quadriplegia)\n* Current symptoms of severe depression, as measured by Center for Epidemiological Studies Depression Scale (CES-D) score\n* Mental retardation or any condition requiring a legal guardian\n* Current or past history of psychotic disorder (schizophrenia, bipolar disorder)\n* Recent or current use (within past 30 days) of select mood or pain or symptom-altering medications:\n\n * benzodiazepine use\n * substance abuse\n * narcotic use\n * antihistamine use\n * barbiturates\n * zaleplon (Sonata)\n* Recent or current use (within past 30 days) of drugs that interact with SJW:\n\n * antidepressants or antipsychotics\n * tramadol (Ultram)\n * sumatriptan (Imitrex)\n * digoxin (Lanoxin)\n * anticonvulsants (e.g. carbamazepine or phenytoin)\n * immunosuppressants: cyclosporine and tacrolimus\n * HIV protease inhibitors (e.g. indinavir), non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine)\n * warfarin (Coumadin)\n * theophylline\n * chemotherapy\n * sulfa-containing drugs\n * piroxicam (Feldene)\n * simvastatin (Zocor)\n * sibutramine (Meridia)\n * verapamil (Calan or Isoptin)\n* Planned surgery (especially transplant) or anesthesia exposure during trial\n* Known photosensitivity or planned photodiagnostic or phototherapy procedures\n* Are pregnant, lactating, likely to become pregnant during medication phase and not willing to use a reliable form of contraception (barrier contraceptives, diaphragm, injections, intrauterine device, surgical sterilization, and abstinence)\n* Recent or current use (within 30 days) of SJW, other herbal products for IBS, investigational drug use\n* Known allergy to SJW\n* Significant acute or chronic progressive neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease\n* Recent history of alcohol or substance dependence use or abuse\n* Another household member or relative participating in the study\n* Professional drivers or operators of heavy machinery\n* Major cardiovascular events in the last 6 months\n* Use of IBS-specific drugs such as tegaserod (Zelnorm) and Lotronex (Alosetron) (within 30 days)"}, 'identificationModule': {'nctId': 'NCT00587860', 'briefTitle': "A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "A Placebo-Controlled Trial of St. John's Wort for Irritable Bowel Syndrome", 'orgStudyIdInfo': {'id': '132-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': "St. John's Wort", 'interventionNames': ["Drug: St. John's wort"]}], 'interventions': [{'name': "St. John's wort", 'type': 'DRUG', 'otherNames': ['Latin name: Hypericum perforatum L.', "Common name: St. John's Wort"], 'description': 'Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day', 'armGroupLabels': ["St. John's Wort"]}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Yuri A. Saito Loftus, M.D. M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yuri A. Saito Loftus, M.D.', 'oldOrganization': 'Mayo Clinic'}}}}