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

Phase 4

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea
• Interventions: Drug: Rifaximin 550 MG; Drug: Psyllium Husk; Drug: Mebeverine 135 MG; Drug: Amitriptyline Hydrochloride 25 MG

• Registration Number: NCT05867550
• Lead Sponsor: Bahria University

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

Study Timeline

• Study Start: 2023-01-03
• Primary Completion: 2023-03-27
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-22
• Study Completion: 2023-06-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C ( Rifaximin + Psyllium Husk )	Psyllium Husk	Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Psyllium Husk 15-30mg once daily per orally for 2 weeks
Group A ( Rifaximin + Mebeverine )	Mebeverine 135 MG	Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Mebeverine 135mg twice daily per orally for 2 weeks
Group B ( Rifaximin + Amitriptyline )	Amitriptyline Hydrochloride 25 MG	Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Amitriptyline 25mg once daily per orally for 2 weeks
Group A ( Rifaximin + Mebeverine )	Rifaximin 550 MG	Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Mebeverine 135mg twice daily per orally for 2 weeks
Group B ( Rifaximin + Amitriptyline )	Rifaximin 550 MG	Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Amitriptyline 25mg once daily per orally for 2 weeks
Group C ( Rifaximin + Psyllium Husk )	Rifaximin 550 MG	Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Psyllium Husk 15-30mg once daily per orally for 2 weeks

Primary Outcome Measures

Name	Time	Method
Compare Efficacy of Treatment Regimes in Treatment Groups	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
Overall Improvement in Characteristic of Diarrhea	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
Overall Improvement in Abdominal Pain	2 Weeks	The study will assess change in abdominal pain from day 0 to day 14
Overall Improvement in Frequency of Diarrhea	2 Weeks	The study will assess change in number of stools per day from day 0 to day 14

Secondary Outcome Measures

Name	Time	Method
To observe adverse effects of treatment regimes	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

Trial Locations

Locations (1)

Bahria University Health Sciences Campus; 🇵🇰 Karachi, Sindh, Pakistan