Health Condition 1: K582- Mixed irritable bowel syndrome
Conditions
Interventions
Intervention1: IBS RCT GROUP A: Severity and quality of life in subjects with Irritable Bowel Syndrome is observed with
Add-on Duloxetine along with treatment as usual. The effects are assessed at bas
Sponsors
KING GEORGES MEDICAL UNIVERSITY
Eligibility
Inclusion criteria
Inclusion criteria: Age group 18-60 years. Diagnosis of IBS as per ROME IV Criteria Written informed consent from Patient.
Exclusion criteria
Exclusion criteria: Patients having medical illness requiring priority management â?? Patients with pre-existing Gastrointestinal disorders other than Functional Gastrointestinal Syndromes, patients with history of gastrointestinal surgery or abnormal upper and lower gastrointestinal endoscopy â?? Patients having chronic medical illness, like chronic kidney disease and diabetes mellitus â?? Patient not receiving psychotropic medication for at least 2 weeks (5 weeks for fluoxetine) â?? Patients with any diagnosable psychiatric disorders as per ICD-10 and having active suicidal ideas â?? Substance use disorders except nicotine in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose: 30mg OD for first 5 days increased to 60mg OD given per oral. Reduction in IBS-SSS & IBS-QOL scores assessed at 2, 4 and 8 weeks of administration of the drug.Timepoint: Reduction in IBS-SSS & IBS-QOL scores assessed at 2, 4 and 8 weeks of administration of the drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose: 30mg OD for first five days increased to 60mg OD per oral for total duration of 8 weeks.Timepoint: Reduction in IBS-SSS & IBS-QOL scores at 2 weeks, 4 weeks and 8 weeks from baseline scores. | — |
Countries
India
Contacts
Public ContactVrinda Purshottam
King Georges Medical University, Lucknow
Outcome results
None listed