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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Irritable Bowel Syndrome With Diarrhea

Intervention / Treatment
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* Drug: Rifaximin 550 MG
* Drug: Mebeverine 135 MG
* Drug: Psyllium Husk
* Drug: Amitriptyline Hydrochloride 25 MG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A ( Rifaximin + Mebeverine )<br>Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Mebeverine 135mg twice daily per orally for 2 weeks | Drug: Rifaximin 550 MG<br>* Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C<br>* Other names: Nixaf 550 MG;Drug: Mebeverine 135 MG<br>* Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes<br>* Other names: Mebever 135 MG;|
| Active Comparator: Group B ( Rifaximin + Amitriptyline )<br>Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Amitriptyline 25mg once daily per orally for 2 weeks | Drug: Rifaximin 550 MG<br>* Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C<br>* Other names: Nixaf 550 MG;Drug: Amitriptyline Hydrochloride 25 MG<br>* Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes<br>* Other names: Tryptanol 25 MG;|
| Active Comparator: Group C ( Rifaximin + Psyllium Husk )<br>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<br>* Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C<br>* Other names: Nixaf 550 MG;Drug: Psyllium Husk<br>* Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes<br>* Other names: Ispaghol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Improvement in Frequency of Diarrhea | 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 | 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 | The study will assess change in abdominal pain from day 0 to day 14 | 2 Weeks | 
| 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 | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Diarrhea, IBS-D