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临床试验/NCT02393430
NCT02393430已完成4 期

Clinical Effect of Rebamipide on Chronic Gastritis

BangMao Wang0 个研究点目标入组 180 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
180
主要终点
modified Lanza score

研究概览

简要总结

To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with chronic gastritis were randomly divided into the experimental group and the control group. The experimental group were treated with rebamipide 0.1g tid and optimization of life style, and the control group were only optimized their life style for 26 weeks. Upper gastrointestinal endoscopy was performed in all patients to evaluate the severity of gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system before and after treatment.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • With the symptoms as follow: epigastric pain, abdominal discomfort, abdominal distention, poor appetite, nausea, vomiting and so on
  • diagnosed as chronic gastritis with endoscopic and pathological methods
  • agree to join in this clinical trail

排除标准

  • 未提供

研究组 & 干预措施

experimental

Experimental

The experimental group were treated with rebamipide 0.1g tid and optimization of life style.

干预措施: Rebamipide (Drug)

experimental

Experimental

The experimental group were treated with rebamipide 0.1g tid and optimization of life style.

干预措施: optimization of life style (Behavioral)

control

Placebo Comparator

The control group were only optimized their life style.

干预措施: optimization of life style (Behavioral)

结局指标

主要结局

modified Lanza score

时间窗: 26 weeks

visual Analog scale

时间窗: 26 weeks

to describe the inflamamtory of gastric mucosa pathologically

次要结局

未报告次要终点

研究者

发起方
BangMao Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

BangMao Wang

Chief of Gastroenterology Department

Tianjin Medical University General Hospital

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