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

Bahria University

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome With Diarrhea

Treatments: Drug: Mebeverine 135 MG; Drug: Psyllium Husk; Drug: Rifaximin 550 MG; Drug: Amitriptyline Hydrochloride 25 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05867550

ERC 106/2022

Details and patient eligibility

About

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

Full 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

Enrollment: 162 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 3 patient groups

Group A ( Rifaximin + Mebeverine )

Active Comparator group

Description:

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

Treatment:

Drug: Rifaximin 550 MG

Drug: Mebeverine 135 MG

Group B ( Rifaximin + Amitriptyline )

Active Comparator group

Description:

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

Treatment:

Drug: Amitriptyline Hydrochloride 25 MG

Drug: Rifaximin 550 MG

Group C ( Rifaximin + Psyllium Husk )

Active Comparator group

Description:

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

Treatment:

Drug: Rifaximin 550 MG

Drug: Psyllium Husk