临床试验/NCT03444831

NCT03444831已完成4 期

Buspirone Plus Omeprazole for Functional Dyspepsia: A Randomised Placebo Clinical Trial

Isfahan University of Medical Sciences0 个研究点目标入组 70 人开始时间: 2016年3月1日最近更新: 2018年2月23日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Isfahan University of Medical Sciences
入组人数: 70
主要终点: 70 patients With functional dyspepsia symptoms, Change From Baseline by asking about symptoms at 4 Weeks after using buspirone or placebo

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Care Provider)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•denied to get these medications
•taking other drugs for FD
•patients with the organic gastrointestinal disorder

研究组 & 干预措施

Buspirone plus Omeprazole

Experimental

干预措施: Buspirone (Drug)

Placebo plus Omeprazole

Placebo Comparator

干预措施: Placebo Oral Tablet (Drug)

结局指标

主要结局

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

时间窗: 4 weeks taking buspirone plus omeprasole or taking placebo plus omeprasloe

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

次要结局

未报告次要终点

研究者

发起方

Isfahan University of Medical Sciences

申办方类型

Other

责任方

Principal Investigator

主要研究者

Meisam AbdarEsfahani

Mediacal Doctor

Isfahan University of Medical Sciences

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