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NCT Number: NCT05867550

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

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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Key information

Conditions

Irritable Bowel Syndrome With Diarrhea Colonic Diseases Colonic Diseases, Functional Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bahria University Health Sciences Campus

Karachi, Sindh, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin 550 MG

Drug

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

Other names: Rifaxa 550MG, Nimixa 550 MG, Xifaxa 550MG, Zerifax 550MG, Nixaf 550 MG

Mebeverine 135 MG

Drug

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

Other names: Colofac 135 MG, Spasler Neo 135 MG, Mebever 135 MG

Psyllium Husk

Drug

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

Other names: Ispaghol

Amitriptyline Hydrochloride 25 MG

Drug

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

Other names: Tryptanol 25 MG

Primary outcomes

  1. Overall Improvement in Frequency of Diarrhea

    Time frame: 2 Weeks

    The study will assess change in number of stools per day from day 0 to day 14

  2. Overall Improvement in Characteristic of Diarrhea

    Time frame: 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

  3. Overall Improvement in Abdominal Pain

    Time frame: 2 Weeks

    The study will assess change in abdominal pain from day 0 to day 14

  4. Compare Efficacy of Treatment Regimes in Treatment Groups

    Time frame: 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

Secondary outcomes

  1. To observe adverse effects of treatment regimes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bahria University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 22, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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