Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Mirtazapine: Tab mirtazapine 15 mg once daily to be taken over and above the routine standard of care for 12 weeks
Control Intervention1: Amitriptyline: Tab amitriptyline 25 mg once dai
Sponsors
Indian Council of Medical Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient diagnosed for Functional Dyspepsia as per ROME-IV criteria, with impaired gastric motility as determined by retained meal value more than 60 per cent at 2 hrs or more than 10 per cent at 4 hrs 2. No overt anxiety or depression as per subscale of HADS–HAS or HDS scores less than 7 3. Age 18-60 yrs 4. Voluntary consent 5. No evidence of structural disease explaining dyspeptic symptoms
Exclusion criteria
Exclusion criteria: Patients with 1. Diabetes mellitus 2. Organic brain syndrome 3. Moderate to Severe Depression 4. History of psychosis, bipolar disorder, substance abuse or dependence 5. Any psychotropic medication 6. Suicidal ideation in past 2wks by PHQ 7. Gastro-esophageal reflux disease (GERD) 8. Concurrent medications affecting GI motility 9. History of gastric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in scores of Short Form Nepean Dyspepsia Index (SF NDI) symptom scale from baseline to 12 weeks of treatment in each periodTimepoint: Baseline, 12 weeks, 14 weeks, 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in score of gastric emptying as assessed by scintigraphyTimepoint: Baseline (before start of intervention), then 12 weeks of treatment;Proportion of patients achieving at least 50% reduction from baseline in symptom score within 4 and 8 weeks of treatmentTimepoint: 4 weeks and 8 weeks of treatment;Proportion of patients with adverse effectsTimepoint: 2 weeks, 4 weeks, 8 weeks, 12 weeks of treatment | — |
Countries
India
Contacts
Public ContactDr Lalit Mohan
Indira Gandhi Institute of Medical Sciences (IGIMS), Patna
Outcome results
None listed