A comparative clinical experiment of mirtazapine and amitriptyline in India on patients with recurring symptoms of an upset stomach that have no obvious cause
- Conditions
- Health Condition 1: K30- Functional dyspepsia
- Registration Number
- CTRI/2024/01/061596
- Lead Sponsor
- Indian Council of Medical Research (ICMR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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