To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 4

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
    

Intervention name(s): Rifaximin 550 MG; Mebeverine 135 MG; Psyllium Husk; Amitriptyline Hydrochloride 25 MG
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): 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
Intervention MeSH terms: Rifaximin; Amitriptyline; Mebeverine; Psyllium; Calcium polycarbophil; Alverine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Diarrhea; IBS-D