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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2023-06-10

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

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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

Conditions

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Irritable Bowel Syndrome With Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A ( Rifaximin + Mebeverine )

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

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

Group Type ACTIVE_COMPARATOR

Rifaximin 550 MG

Intervention Type DRUG

Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C

Mebeverine 135 MG

Intervention Type DRUG

Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes

Group B ( Rifaximin + Amitriptyline )

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

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

Group Type ACTIVE_COMPARATOR

Rifaximin 550 MG

Intervention Type DRUG

Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C

Amitriptyline Hydrochloride 25 MG

Intervention Type DRUG

Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes

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

Group Type ACTIVE_COMPARATOR

Rifaximin 550 MG

Intervention Type DRUG

Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C

Psyllium Husk

Intervention Type DRUG

Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes

Interventions

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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

Intervention Type DRUG

Mebeverine 135 MG

Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes

Intervention Type DRUG

Psyllium Husk

Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes

Intervention Type DRUG

Amitriptyline Hydrochloride 25 MG

Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes

Intervention Type DRUG

Other Intervention Names

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Rifaxa 550MG Nimixa 550 MG Xifaxa 550MG Zerifax 550MG Nixaf 550 MG Colofac 135 MG Spasler Neo 135 MG Mebever 135 MG Ispaghol Tryptanol 25 MG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No