Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-03 @ 8:17 PM
Study NCT ID:
NCT02538692
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2015-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2015-08-30', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks.', 'timeFrame': '4 weeks after initiation of treatment'}], 'secondaryOutcomes': [{'measure': 'Stool frequency per week', 'timeFrame': 'baseline(week 0), week 4, week 8, week 12'}, {'measure': 'An visual scale rating the degree of IBS-D symptoms', 'timeFrame': 'baseline(week 0), week 4, week 8, week 12', 'description': 'The scale ranges from 0 to 10. The score 0 indicates the mildest degree, while the 10 indicates the most serious degree.'}, {'measure': 'Proportion of adverse events', 'timeFrame': 'week 4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diarrhea-predominant Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '29856472', 'type': 'DERIVED', 'citation': 'Chen M, Tang TC, Wang Y, Shui J, Xiao XH, Lan X, Yu P, Zhang C, Wang SH, Yao J, Zheng H, Huang DQ. Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2018 Jul;48(2):160-168. doi: 10.1111/apt.14817. Epub 2018 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the efficacy and safety of a traditional Chinese medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome (IBS-D).', 'detailedDescription': 'Participants: The sample size of this trial is 118, to test an odds ratio of 3.5 at a significance of 0.05 and power of 0.8.\n\nIntervention: Tong-Xie-Yao-Fang versus placebo Data collection: Standard operation procedure will be developed for how to interviewing the participants, how to use the IBS diary, how to enter the data into the electronic case report forms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed as IBS according to the Rome III criteria;\n* Diarrhea was present for at least 75% of the time;\n* With a TCM differentiation as "liver stagnation and spleen defficiency"\n* Had a colonoscopy within a year to rule out other bowel diseases.\n\nExclusion Criteria:\n\n* Organic gastrointestinal disease, such as colorectal cancer, inflammatory bowel disease, advanced colonic polyp;\n* Had gastrointestinal surgery within a year;\n* Used durgs that affect gastrointestinal motility;\n* Had psychological disorder;\n* Serious disease in other system, which may bias the outcome measures.'}, 'identificationModule': {'nctId': 'NCT02538692', 'briefTitle': 'Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu University of Traditional Chinese Medicine'}, 'officialTitle': 'Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study', 'orgStudyIdInfo': {'id': '81373644'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tong-Xie-Yao-Fang', 'description': 'Tong-Xie-Yao-Fang is a classic formula of traditional Chinese medicine for IBS-D. It is composed of 4 herbs: Radix Paeoniae Alba, Ledebouriella seseloides Wolff, pericarpium citri reticulatae and Rhizoma Atractylodis Macrocephalae. The granules will be administrated for thrice daily at a dose of 15g per time. The total duration of treatment is 4 weeks.', 'interventionNames': ['Drug: Tong-Xie-Yao-Fang']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'It is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tong-Xie-Yao-Fang', 'type': 'DRUG', 'otherNames': ['Tongxieyaofang'], 'description': 'Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.', 'armGroupLabels': ['Tong-Xie-Yao-Fang']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The placebo is the same as Tong-Xie-Yao-Fang in appearance.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610075', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Teaching Hospital of Chengdu University of TCM', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}