NCT05867550

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Bahria University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
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
DRUG	Mebeverine 135 MG	Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes
DRUG	Psyllium Husk	Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes
DRUG	Amitriptyline Hydrochloride 25 MG	Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes

Timeline

• Start date: 2023-01-03
• Primary completion: 2023-03-27
• Completion: 2023-06-10
• First posted: 2023-05-22
• Last updated: 2023-07-27

Locations

1 site across 1 country: Pakistan