NCT02356679已完成4 期
A Phase 4, Multicenter, Randomized, Open, Active Drug Comparative Trial to Evaluated the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 10
- 主要终点
- cure rate of erosion
研究概览
简要总结
The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients.
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
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is 19 years old and over, men or women
- •Patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms
- •Patients with one or more erosions found by gastroscopy
- •Patients who voluntarily signed written informed consent may participate in the study
排除标准
- •Patients with peptic ulcer and gastroesophageal reflux disease
- •Patients with Gastrointestinal malignant tumor or surgery related to stomach resection
- •Patients with thromboembolism and coagulation disorder
- •Patients with significant cardiovascular, pulmonary, heptic, renal primary disease
- •Patients with abnormal laboratory result at screening
- •Aspartate aminotransferase(AST), Alanine aminotransferase(ALT), Creatinine > upper limit of normal range x 2
- •White blood cell(WBC) < 4,000/mm3
- •Platelet < 50,000/mm3
- •Patients administered with H2 receptor antagonists, proton pump inhibitors, muscarine receptor antagonists, other gastiritis treatment drug, protective factor builder, non-steroid anti-inflammatory drugs prior to study in 2 weeks
- •History of allergic reaction to the investigational product
- •Women either pregnant, breast feeding or possible to pregnant without contraceptive method
- •Use of other investigational drugs within 3 months prior to the study
- •Patients that investigators consider ineligible for this study
研究组 & 干预措施
Eupasidin-s tab.
Experimental
three times per day, 1 tab for each time, PO, during 2weeks
干预措施: Eupasidin-s Tab (Drug)
Stillen tab.
Active Comparator
three times per day, 1 tab for each time, PO, during 2weeks
干预措施: Stillen Tab. (Drug)
结局指标
主要结局
cure rate of erosion
时间窗: 2 weeks
次要结局
- improvement rate of erosion(2 weeks)
- improvement rate of edema(2 weeks)
- improvement rate of erythema(2 weeks)
- improvement rate of hemorrhage(2 weeks)
- improvement rate of self symptoms(2 weeks)
研究者
研究点 (10)
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