CTRI/2024/01/061596
Not yet recruiting
未知
Effect of Mirtazapine as add-on treatment in functional dyspepsia with impaired gastric emptying compared to Amitriptyline – a Randomized Cross-over Trial from India - Nil
Indian Council of Medical Research (ICMR)0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: K30- Functional dyspepsia
- Sponsor
- Indian Council of Medical Research (ICMR)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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