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

July 25, 2023 updated by: Rashid Ali Khosa, Bahria University

To Compare the Efficacy of (Rifaximin + Mebeverine), (Rifaximin + Amitriptyline), and (Rifaximin + Psyllium Husk) in Irritable Bowel Syndrome Associated With Diarrhea

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Bahria University Health Sciences Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A ( Rifaximin + Mebeverine )

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

Tab. Mebeverine 135mg twice daily per orally for 2 weeks
Drug: Rifaximin 550 MG
Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C
Other Names:
  • Rifaxa 550MG
  • Nimixa 550 MG
  • Xifaxa 550MG
  • Zerifax 550MG
  • Nixaf 550 MG
Drug: Mebeverine 135 MG
Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes
Other Names:
  • Colofac 135 MG
  • Spasler Neo 135 MG
  • Mebever 135 MG
Active Comparator: Group B ( Rifaximin + Amitriptyline )

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

Tab. Amitriptyline 25mg once daily per orally for 2 weeks
Drug: Rifaximin 550 MG
Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C
Other Names:
  • Rifaxa 550MG
  • Nimixa 550 MG
  • Xifaxa 550MG
  • Zerifax 550MG
  • Nixaf 550 MG
Drug: Amitriptyline Hydrochloride 25 MG
Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes
Other Names:
  • Tryptanol 25 MG
Active Comparator: Group C ( Rifaximin + Psyllium Husk )

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

Psyllium Husk 15-30mg once daily per orally for 2 weeks
Drug: Rifaximin 550 MG
Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C
Other Names:
  • Rifaxa 550MG
  • Nimixa 550 MG
  • Xifaxa 550MG
  • Zerifax 550MG
  • Nixaf 550 MG
Drug: Psyllium Husk
Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes
Other Names:
  • Ispaghol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Improvement in Frequency of Diarrhea
Time Frame: 2 Weeks
The study will assess change in number of stools per day from day 0 to day 14
2 Weeks
Overall Improvement in Characteristic of Diarrhea
Time Frame: 2 Weeks
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
2 Weeks
Overall Improvement in Abdominal Pain
Time Frame: 2 Weeks
The study will assess change in abdominal pain from day 0 to day 14
2 Weeks
Compare Efficacy of Treatment Regimes in Treatment Groups
Time Frame: 4 Weeks
The study will assess and compare the effect of each treatment regime on reduction of diarrhea, improvement in abdominal pain among the treatment groups
4 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To observe adverse effects of treatment regimes
Time Frame: 2 Weeks
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
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahria University

Investigators

  • Principal Investigator: Rashid Ali, Bahria University Health Science Campus Karachi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Actual)

March 27, 2023

Study Completion (Actual)

June 10, 2023

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC 106/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome With Diarrhea

Clinical Trials on Rifaximin 550 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe