Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-02 @ 3:46 AM
Study NCT ID:
NCT03300804
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2010-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2010-03-28', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global IBS symptom improvement', 'timeFrame': '8 weeks', 'description': "The primary endpoint for this study is the efficacy at the 8 week followup visit of the herbal formulations, which is defined by the patient's global assessment of the IBS symptoms."}], 'secondaryOutcomes': [{'measure': 'The Bowel Symptom Scale (BSS):', 'timeFrame': '8 weeks', 'description': 'The Bowel Symptom Scale will be used to assess changes in individual IBS and global IBS symptoms during the course of illness.'}, {'measure': 'SF-36', 'timeFrame': '8 weeks', 'description': 'Quality of Life generic (SF-36), will be used for assessment of quality of life in response to treatment.'}, {'measure': 'IBS-QoL', 'timeFrame': '8 weeks', 'description': 'Disease-specific (IBS-QoL) will be used for assessment of quality of life in response to treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IBS'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to identify efficacious and safe dosage of the formulation in treating IBS.', 'detailedDescription': 'The Specific aims of the project are:\n\n1. To determine whether a 20- herb formulation improves pain/ discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed with current conventional Western medicine.\n2. To identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized clinical trial, in conjunction with indices of safety and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18- 75\n* All IBS patients attending the Gastroenterology Clinic of the Prince Of Wales Hospital of Hong Kong.\n* IBS diagnosed by Rome III criteria:\n\n * Recurrent abdominal pain or discomfort at least three days per month in the previous three months\n * Symptoms onset at least six months prior to diagnose\n * Pain or discomfort associated with two or more of the following:\n\n 1. Improvement with defecation\n 2. Onset associated with change in frequency of stool\n 3. Onset associated with a change in form (appearance) of stool\n* Normal colonic evaluation (colonoscopy or barium enema) in past 5 years\n* No "global symptom improvement" as rated by patients (see below) at screening and during the two- week run- in period to baseline\n* Normal full blood count, liver function test and renal function test.\n\n * Informed written consent for participation into study.\n * Ethical approval will be obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee as well as the IRB of UMB.\n\nExclusion Criteria:\n\n* Past or present history of organic disease of gastrointestinal tract (e.g. colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, peptic ulcer and previous gastrointestinal surgery). (Note: those with polyps removed during colonoscopy can be included, as long as no known polyps remained.\n* Systemic diseases that cause diarrhea or constipation (e.g. thyroid disease, diabetic neuropathy)\n* Lactose intolerance\n* Severe liver disease (e.g. cirrhosis, chronic active hepatitis)\n* Renal impairment (serum creatinine level \\> 150mmol/L)\n* Women who are pregnant, lactating or not practicing proper contraception\n* Known hypersensitivity to herbal medicine\n* Concommitant use of prescription antidepressant medication\n* Current alcoholism and drug use\n* Current psychiatric illness or dementia\n* Fever or severe illness at baseline (week 0).'}, 'identificationModule': {'nctId': 'NCT03300804', 'acronym': 'TCM-IBS', 'briefTitle': 'Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'HP-00041236'}, 'secondaryIdInfos': [{'id': '1U19AT003266-01', 'link': 'https://reporter.nih.gov/quickSearch/1U19AT003266-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '20-herb formulation', 'description': 'Active herb', 'interventionNames': ['Drug: 20-herb formulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo herb formulation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '20-herb formulation', 'type': 'DRUG', 'description': 'Two daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks', 'armGroupLabels': ['20-herb formulation']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo herb formulation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Brian M Berman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research Center for Integrative Medicine, University of Maryland', 'investigatorFullName': 'Brian Berman', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}