Buspirone Plus Omeprazole for Functional Dyspepsia

Isfahan University of Medical Sciences70 enrolled

Overview

This study is a double-blinded Randomised clinical trial aim to compare buspirone plus omeprazole with placebo plus omeprazole.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dyspepsia

Interventions

BuspironeDRUG

Buspirone 5mg used QID a day after meal plus 20mg omeprazole before breakfast.

Placebo Oral TabletDRUG

Buspirone placebo QID after meal plus 20mg omeprazole before breakfast.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * being over 18-year-old, Rome III criteria for FD * normal upper endoscopy within five years * negative Urease test for H-pylori * acceptance informed concept form. Exclusion Criteria: * denied to get these medications * taking other drugs for FD * patients with the organic gastrointestinal disorder

Outcomes

Primary Outcomes

70 patients With functional dyspepsia symptoms, Change From Baseline by asking about symptoms at 4 Weeks after using buspirone or placebo

Global symptom measured through a checklist of dyspepsia symptoms at first visit and four weeks after

Time frame: 4 weeks taking buspirone plus omeprasole or taking placebo plus omeprasloe

Data from ClinicalTrials.gov

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