Health Condition 1: K580- Irritable bowel syndrome with diarrhea
Conditions
Interventions
Intervention1: Rifaximin and Bismuth subcitrate: Tab. Rifaximin 550 mg twice a day for 14 days and Tab. Bismuth Subcitrate 120 mg twice a day for 14 days.
Control Intervention1: Mebeverine: Tab. Mebev
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1) Patients with IBS-D aged 18?49 years, 2) Diagnosed according to the Rome IV criteria.
Exclusion criteria
Exclusion criteria: 1) Old aged patients ( more than 50yrs) 2) Pregnant women 3) Documented chronic heart or liver failure 4) Surgery on the gastrointestinal tract except appendectomy 5) Malabsorption diseases 6) Hyperthyroidism, Diabetes mellitus 7) Inflammatory bowel diseases 8) Connective tissue diseases 9) Use of antibiotic drugs within 1 month before the study 10) Significant weight loss, fever, and bloody stools 11) Lost to follow up 12) Drugs affecting gut motility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To evaluate improvement in abdominal pain using 11 points NRS scale. 2)To evaluate improvement in BSFS. Timepoint: 1) visit 3 -2nd week( site visit) 2) Visit 5- 4th week ( site visit) 3) Visit 7 - 3rd month( site visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To evaluate the responder rates for abdominal pain & stool abnormalities separately. 2) To evaluate stool frequency (CSBM & SBM) & stool consistency in both arms. 3) To evaluate abdominal pain & the evaluation of the number of pain free days. 4) To evaluate the numerical & responder on abdominal discomfort & bloating. 5) To evaluate urgency of defecation, distension. 6) To evaluate the Quality of Life using validated generic & disease specific Quality of Life scales. Timepoint: 1) Visit 2- 1st week telephonic visit 2) Visit 3- 2nd week site visit 3) Visit 4-3rd week telephonic visit 4) Visit 5- 4th week site visit 5) Visit 6- 2nd month telephonic visit 6) Visit 7-3rd month site visit. | — |
Countries
India
Contacts
Public ContactDrAmol Dahale
Dr D.Y. Patil Medical Hospital and Research Institute
Outcome results
None listed