search
Back to results

To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea

Primary Purpose

Irritable Bowel Syndrome With Diarrhea

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Rifaximin 550 MG
Mebeverine 135 MG
Psyllium Husk
Amitriptyline Hydrochloride 25 MG
Sponsored by
Bahria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea focused on measuring Irritable Bowel Syndrome, Diarrhea, IBS-D

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individual of both gender between the age of 18-50 years Diagnosed case of Irritable Bowel Syndrome associated with Diarrhea Exclusion Criteria: Presence of co morbid diseases Coronary Artery Disease (CAD) Chronic Obstructive Pulmonary Disease (COPD) Congestive Heart Failure (CHF) Patients taking drugs which modify or aggravate symptoms of IBS (antidepressants, calcium channel blockers etc.) Patients having hyperthyroidism & gluten hypersensitivity Patients with alarming symptoms, viz. history of fever, passage of blood in stool, loss of weight, any organic gastrointestinal disease in the recent past 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 Patients with Irritable Bowel Disease and Celiac disease

Sites / Locations

  • Bahria University Health Sciences Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A ( Rifaximin + Mebeverine )

Group B ( Rifaximin + Amitriptyline )

Group C ( Rifaximin + Psyllium Husk )

Arm Description

Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Mebeverine 135mg twice daily per orally for 2 weeks

Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Amitriptyline 25mg once daily per orally for 2 weeks

Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Psyllium Husk 15-30mg once daily per orally for 2 weeks

Outcomes

Primary Outcome Measures

Overall Improvement in Frequency of Diarrhea
The study will assess change in number of stools per day from day 0 to day 14
Overall Improvement in Characteristic of Diarrhea
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
Overall Improvement in Abdominal Pain
The study will assess change in abdominal pain from day 0 to day 14
Compare Efficacy of Treatment Regimes in Treatment Groups
The study will assess and compare the effect of each treatment regime on reduction of diarrhea, improvement in abdominal pain among the treatment groups

Secondary Outcome Measures

To observe adverse effects of treatment regimes
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

Full Information

First Posted
April 4, 2023
Last Updated
July 25, 2023
Sponsor
Bahria University
search

1. Study Identification

Unique Protocol Identification Number
NCT05867550
Brief Title
To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea
Official Title
To Compare the Efficacy of (Rifaximin + Mebeverine), (Rifaximin + Amitriptyline), and (Rifaximin + Psyllium Husk) in Irritable Bowel Syndrome Associated With Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
March 27, 2023 (Actual)
Study Completion Date
June 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea? Participants will be divided into 3 treatment groups. Each group will be given a combination of drugs for 2 weeks At the end of study, efficacy of different drug combinations and their potential side effects will be compared between the treatment groups
Detailed Description
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: • Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea? Total of 162 Participants will be enrolled in study. Participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C. Participants of Group A will receive drug combination of Rifaximin and Mebeverine Participants of Group B will receive drug combination of Rifaximin and Amitriptyline Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk Each group will be given a combination of drugs for 2 weeks Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention Data will be collected using Questionnaire. Questionnaire will be filled by the researcher SPSS 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea
Keywords
Irritable Bowel Syndrome, Diarrhea, IBS-D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial in which participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C. Participants of Group A will receive drug combination of Rifaximin and Mebeverine Participants of Group B will receive drug combination of Rifaximin and Amitriptyline Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk Each group will be given a combination of drugs for 2 weeks Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention At the end of study period , efficacy of different drug combinations and their potential side effects will be compared between the treatment groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A ( Rifaximin + Mebeverine )
Arm Type
Active Comparator
Arm Description
Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Mebeverine 135mg twice daily per orally for 2 weeks
Arm Title
Group B ( Rifaximin + Amitriptyline )
Arm Type
Active Comparator
Arm Description
Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Amitriptyline 25mg once daily per orally for 2 weeks
Arm Title
Group C ( Rifaximin + Psyllium Husk )
Arm Type
Active Comparator
Arm Description
Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Psyllium Husk 15-30mg once daily per orally for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Rifaximin 550 MG
Other Intervention Name(s)
Rifaxa 550MG, Nimixa 550 MG, Xifaxa 550MG, Zerifax 550MG, Nixaf 550 MG
Intervention Description
Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C
Intervention Type
Drug
Intervention Name(s)
Mebeverine 135 MG
Other Intervention Name(s)
Colofac 135 MG, Spasler Neo 135 MG, Mebever 135 MG
Intervention Description
Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes
Intervention Type
Drug
Intervention Name(s)
Psyllium Husk
Other Intervention Name(s)
Ispaghol
Intervention Description
Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes
Intervention Type
Drug
Intervention Name(s)
Amitriptyline Hydrochloride 25 MG
Other Intervention Name(s)
Tryptanol 25 MG
Intervention Description
Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes
Primary Outcome Measure Information:
Title
Overall Improvement in Frequency of Diarrhea
Description
The study will assess change in number of stools per day from day 0 to day 14
Time Frame
2 Weeks
Title
Overall Improvement in Characteristic of Diarrhea
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
Time Frame
2 Weeks
Title
Overall Improvement in Abdominal Pain
Description
The study will assess change in abdominal pain from day 0 to day 14
Time Frame
2 Weeks
Title
Compare Efficacy of Treatment Regimes in Treatment Groups
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
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
To observe adverse effects of treatment regimes
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
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individual of both gender between the age of 18-50 years Diagnosed case of Irritable Bowel Syndrome associated with Diarrhea Exclusion Criteria: Presence of co morbid diseases Coronary Artery Disease (CAD) Chronic Obstructive Pulmonary Disease (COPD) Congestive Heart Failure (CHF) Patients taking drugs which modify or aggravate symptoms of IBS (antidepressants, calcium channel blockers etc.) Patients having hyperthyroidism & gluten hypersensitivity Patients with alarming symptoms, viz. history of fever, passage of blood in stool, loss of weight, any organic gastrointestinal disease in the recent past 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 Patients with Irritable Bowel Disease and Celiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashid Ali
Organizational Affiliation
Bahria University Health Science Campus Karachi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahria University Health Sciences Campus
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD data will be shared
IPD Sharing Time Frame
IPD data will be available 01 year after publication and will be available perpetually
IPD Sharing Access Criteria
All the data will be assessable to all
Citations:
PubMed Identifier
28367168
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.
Results Reference
background
PubMed Identifier
33946961
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.
Results Reference
background
PubMed Identifier
30400292
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.
Results Reference
background
PubMed Identifier
33564537
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.
Results Reference
background
PubMed Identifier
27862281
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.
Results Reference
background
PubMed Identifier
30460770
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.
Results Reference
background

Learn more about this trial

To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea

We'll reach out to this number within 24 hrs