Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 1:39 PM
Study NCT ID:
NCT05867550
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003967', 'term': 'Diarrhea'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}, {'id': 'C005096', 'term': 'mebeverine'}, {'id': 'D011620', 'term': 'Psyllium'}, {'id': 'D000639', 'term': 'Amitriptyline'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Control Trial in which participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C.\n\n* Participants of Group A will receive drug combination of Rifaximin and Mebeverine\n* Participants of Group B will receive drug combination of Rifaximin and Amitriptyline\n* Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk\n* Each group will be given a combination of drugs for 2 weeks\n\nStool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention\n\nAt the end of study period , efficacy of different drug combinations and their potential side effects will be compared between the treatment groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Improvement in Frequency of Diarrhea', 'timeFrame': '2 Weeks', 'description': 'The study will assess change in number of stools per day from day 0 to day 14'}, {'measure': 'Overall Improvement in Characteristic of Diarrhea', 'timeFrame': '2 Weeks', 'description': 'The study will assess change in characteristic of stool type from type 6,7 to 4 according to Bristol Stool Chart from day 0 to day 14'}, {'measure': 'Overall Improvement in Abdominal Pain', 'timeFrame': '2 Weeks', 'description': 'The study will assess change in abdominal pain from day 0 to day 14'}, {'measure': 'Compare Efficacy of Treatment Regimes in Treatment Groups', 'timeFrame': '4 Weeks', 'description': 'The study will assess and compare the effect of each treatment regime on reduction of diarrhea, improvement in abdominal pain among the treatment groups'}], 'secondaryOutcomes': [{'measure': 'To observe adverse effects of treatment regimes', 'timeFrame': '2 Weeks', 'description': 'The study will observe number of participants with adverse effects like Nausea, Stomachache, Dizziness, Tiredness, Joint Pain, Headache, Heartburn, Constipation, Dry Mouth, Sedation and Bloating of drugs in different groups and compare them'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Diarrhea', 'IBS-D'], 'conditions': ['Irritable Bowel Syndrome With Diarrhea']}, 'referencesModule': {'references': [{'pmid': '28367168', 'type': 'BACKGROUND', 'citation': 'Alaqeel MK, Alowaimer NA, Alonezan AF, Almegbel NY, Alaujan FY. Prevalence of Irritable Bowel Syndrome and its Association with Anxiety among Medical Students at King Saud bin Abdulaziz University for Health Sciences in Riyadh. Pak J Med Sci. 2017 Jan-Feb;33(1):33-36. doi: 10.12669/pjms.331.12572.'}, {'pmid': '33946961', 'type': 'BACKGROUND', 'citation': 'Altomare A, Di Rosa C, Imperia E, Emerenziani S, Cicala M, Guarino MPL. Diarrhea Predominant-Irritable Bowel Syndrome (IBS-D): Effects of Different Nutritional Patterns on Intestinal Dysbiosis and Symptoms. Nutrients. 2021 Apr 29;13(5):1506. doi: 10.3390/nu13051506.'}, {'pmid': '30400292', 'type': 'BACKGROUND', 'citation': 'Axelrod CH, Saps M. The Role of Fiber in the Treatment of Functional Gastrointestinal Disorders in Children. Nutrients. 2018 Nov 3;10(11):1650. doi: 10.3390/nu10111650.'}, {'pmid': '33564537', 'type': 'BACKGROUND', 'citation': 'Bachani P, Kumar L, Kumar N, Fatima M, Naz S, Memon MK, Memon S, Rizwan A. Prevalence of Irritable Bowel Syndrome and Frequency of Symptoms in the General Population of Pakistan. Cureus. 2021 Jan 6;13(1):e12541. doi: 10.7759/cureus.12541.'}, {'pmid': '27862281', 'type': 'BACKGROUND', 'citation': 'Bai T, Xia J, Jiang Y, Cao H, Zhao Y, Zhang L, Wang H, Song J, Hou X. Comparison of the Rome IV and Rome III criteria for IBS diagnosis: A cross-sectional survey. J Gastroenterol Hepatol. 2017 May;32(5):1018-1025. doi: 10.1111/jgh.13642.'}, {'pmid': '30460770', 'type': 'BACKGROUND', 'citation': 'Barbara G, Cremon C, Azpiroz F. Probiotics in irritable bowel syndrome: Where are we? Neurogastroenterol Motil. 2018 Dec;30(12):e13513. doi: 10.1111/nmo.13513.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the efficacy of four different drugs in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:\n\n* Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea?\n\nParticipants will be divided into 3 treatment groups.\n\n* Each group will be given a combination of drugs for 2 weeks\n* At the end of study, efficacy of different drug combinations and their potential side effects will be compared between the treatment groups', 'detailedDescription': 'The goal of this clinical trial is to compare the efficacy of four different drugs (Rifaximin , Mebeverine, Amitriptyline and Psyllium Husk) in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:\n\n• Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea?\n\nTotal of 162 Participants will be enrolled in study.\n\n* Participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C.\n* Participants of Group A will receive drug combination of Rifaximin and Mebeverine\n* Participants of Group B will receive drug combination of Rifaximin and Amitriptyline\n* Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk\n* Each group will be given a combination of drugs for 2 weeks\n\nStool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention\n\nData will be collected using Questionnaire. Questionnaire will be filled by the researcher\n\nSPSS will be used for analysis of data and appropriate test like Chi square Test, Student T test and One way ANOVA will be used to draw conclusions about the efficacy of different drug combinations and their potential side effects between the treatment groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividual of both gender between the age of 18-50 years Diagnosed case of Irritable Bowel Syndrome associated with Diarrhea\n\nExclusion Criteria:\n\n* Presence of co morbid diseases\n* Coronary Artery Disease (CAD)\n* Chronic Obstructive Pulmonary Disease (COPD)\n* Congestive Heart Failure (CHF)\n* Patients taking drugs which modify or aggravate symptoms of IBS (antidepressants, calcium channel blockers etc.)\n* Patients having hyperthyroidism \\& gluten hypersensitivity\n* Patients with alarming symptoms, viz. history of fever, passage of blood in stool, loss of weight, any organic gastrointestinal disease in the recent past\n* Patients with recent change in bowel habits, patients on any other concomitant medication for abdominal pain, bowel disturbance or altering gastrointestinal motility and malignancy of any other organ\n* Patients with Irritable Bowel Disease and Celiac disease'}, 'identificationModule': {'nctId': 'NCT05867550', 'briefTitle': 'To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'Bahria University'}, 'officialTitle': 'To Compare the Efficacy of (Rifaximin + Mebeverine), (Rifaximin + Amitriptyline), and (Rifaximin + Psyllium Husk) in Irritable Bowel Syndrome Associated With Diarrhea', 'orgStudyIdInfo': {'id': 'ERC 106/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A ( Rifaximin + Mebeverine )', 'description': 'Tab. Rifaximin 550mg thrice daily per orally for 2 weeks\n\nTab. Mebeverine 135mg twice daily per orally for 2 weeks', 'interventionNames': ['Drug: Rifaximin 550 MG', 'Drug: Mebeverine 135 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B ( Rifaximin + Amitriptyline )', 'description': 'Tab. Rifaximin 550mg thrice daily per orally for 2 weeks\n\nTab. Amitriptyline 25mg once daily per orally for 2 weeks', 'interventionNames': ['Drug: Rifaximin 550 MG', 'Drug: Amitriptyline Hydrochloride 25 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C ( Rifaximin + Psyllium Husk )', 'description': 'Tab. Rifaximin 550mg thrice daily per orally for 2 weeks\n\nPsyllium Husk 15-30mg once daily per orally for 2 weeks', 'interventionNames': ['Drug: Rifaximin 550 MG', 'Drug: Psyllium Husk']}], 'interventions': [{'name': 'Rifaximin 550 MG', 'type': 'DRUG', 'otherNames': ['Rifaxa 550MG', 'Nimixa 550 MG', 'Xifaxa 550MG', 'Zerifax 550MG', 'Nixaf 550 MG'], 'description': 'Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C', 'armGroupLabels': ['Group A ( Rifaximin + Mebeverine )', 'Group B ( Rifaximin + Amitriptyline )', 'Group C ( Rifaximin + Psyllium Husk )']}, {'name': 'Mebeverine 135 MG', 'type': 'DRUG', 'otherNames': ['Colofac 135 MG', 'Spasler Neo 135 MG', 'Mebever 135 MG'], 'description': 'Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes', 'armGroupLabels': ['Group A ( Rifaximin + Mebeverine )']}, {'name': 'Psyllium Husk', 'type': 'DRUG', 'otherNames': ['Ispaghol'], 'description': 'Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes', 'armGroupLabels': ['Group C ( Rifaximin + Psyllium Husk )']}, {'name': 'Amitriptyline Hydrochloride 25 MG', 'type': 'DRUG', 'otherNames': ['Tryptanol 25 MG'], 'description': 'Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes', 'armGroupLabels': ['Group B ( Rifaximin + Amitriptyline )']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Bahria University Health Sciences Campus', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Rashid Ali', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bahria University Health Science Campus Karachi'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'IPD data will be available 01 year after publication and will be available perpetually', 'ipdSharing': 'YES', 'description': 'All collected IPD data will be shared', 'accessCriteria': 'All the data will be assessable to all'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bahria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Rashid Ali Khosa', 'investigatorAffiliation': 'Bahria University'}}}}