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Clinical Trials/CTRI/2024/01/061596
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Indian Council of Medical Research (ICMR)

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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