The Effect of 3-day Oral Administration of Lamina-G on Epigastric Pain or Soreness After Gastric Biopsy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- gastrointestinal symptom
研究概览
简要总结
Sometimes, subjects complain about gastrointestinal symptoms after esophagogastroduodenoscopy and biopsy. The aim of this study is to investigate the effect of sodium alginate (Lamina-G®) on biopsy-related gastrointestinal symptom.
详细描述
This study is an open labeled, single-center randomized controlled trials. Patients who underwent upper enoscopy with biopsy were randomly assigned to medication and control group. In the medication group, sodium alginate was administered after EGD during 3 days. All patients underwent a questionnaire to check the presence of gastrointestinal symptoms at baseline and on the day after return home. After 3 days, gastrointestinal symptoms were investigated by telephone survey. Gastrointestinal symptom was scaled by upper gastrointestinal symptom rate score (GSRS). Upper GSRS contains 8 items and 3 scales; abdominal pain (abdominal pain, epigastric pain/hunger soreness, nausea), reflux symptom (Heartburn/reflux/belching gas), indigestion symptom (abdominal distension, borborygmus).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 18 to 80 years Persons who assigned on the written consent for the clinical trial. Persons who underwent upper endoscopy and gastric biopsy
排除标准
- •Gastrectomy Severe cardiovascular, pulmonary, or endocrine disease Renal or hepatic dysfunction Hematologic disease Gastric cancer Active peptic ulcer User of proton pump inhibitor, H2 blocker, mucoprotectant Immediate significant bleeding after biopsy Pregnant women Allergy history for sodium alginate
研究组 & 干预措施
treatment
oral administration of sodium alginate (LaminaG) after gastric biopsy
干预措施: Sodium alginate (Drug)
结局指标
主要结局
gastrointestinal symptom
时间窗: 3 days after endoscopy (T3)
Upper Gastrointestinal Symptom Rating Scale (8 domain) : score : 0,1,2,3 in each domain (0: none, 3: severe)
次要结局
未报告次要终点
研究者
Su Youn Nam
Assistant Professor
Kyungpook National University Hospital