NCT01817556已完成4 期
A Multicenter, Active-controlled, Randomized, Double-blind Paralleled-group Clinical Trial to Evaluate the Efficacy of 4-week Treatment With Stillen Tab. in Patients With Acute or Chronic Gastritis
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
- 258
- 试验地点
- 1
- 主要终点
- Improvement rates of erosive gastritis
研究概览
简要总结
This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three times a day for four weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is over 20 years old, under 75 years old, men or women
- •Patients diagnosed with acute or chronic gastritis by gastroscopy
- •Patients with one or more erosions found by gastroscopy
- •Signed the informed consent forms
排除标准
- •Patients with peptic ulcer and gastroesophageal reflux disease
- •Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
- •Patients with surgery related to gastroesophageal
- •Patients with Zollinger-Ellison syndrome
- •Patients with any kind of malignant tumor
- •Patients administered with anti-thrombotic drugs
- •Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
- •Women either pregnant or breast feeding
研究组 & 干预措施
Stillen Tab.
Experimental
administered three times daily for four weeks
干预措施: Stillen Tab. (Drug)
Mucosta Tab.
Active Comparator
administered three times daily for four weeks
干预措施: Mucosta Tab. (Drug)
结局指标
主要结局
Improvement rates of erosive gastritis
时间窗: 4 weeks
Improvement rates of erosive gastritis (%) = (improved cases)/(total cases administered) \* 100
次要结局
- Symptoms improved level(4 weeks)
- Healing rates of erosive gastritis(4 weeks)
研究者
研究点 (1)
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