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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
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 Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes
Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes
Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes
Bahria University Health Sciences Campus
Karachi, Sindh, Pakistan
Overall Improvement in Frequency of Diarrhea
The study will assess change in number of stools per day from day 0 to day 14
Time frame: 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
Time frame: 2 Weeks
Overall Improvement in Abdominal Pain
The study will assess change in abdominal pain from day 0 to day 14
Time frame: 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
Time frame: 4 Weeks
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
Time frame: 2 Weeks
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