NCT01735136已完成不适用
Efficacy and Safety of InSan Bamboo Salt on Improvement of Helicobacter Pylori Infection
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in 14C-UBT(Urea breath test)
研究概览
简要总结
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of InSan Bamboo Salt on improvement of Helicobacter pylori infection. The investigators measured improvement of Helicobacter pylori infection parameters , including 14C-UBT(Urea breath test), and subjects' symptoms, and monitored their blood pressure.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 19-65 years old
- •14C-UBT test ≥ 100 cpm
- •Endoscopy results showing gastritis
- •Able to give informed consent
排除标准
- •Diagnosed of gastrointestinal disease such as ulcer, cancer, more than 10 erosions
- •Taken antibiotics and stomach medicines such as steroid, bismuth compound, H2-receptor antagonist and proton pump inhibitor within 2 weeks
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnant or lactating women etc.
研究组 & 干预措施
InSan Bamboo Salt
Experimental
干预措施: InSan Bamboo Salt (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in 14C-UBT(Urea breath test)
时间窗: 4 weeks
14C-UBT(Urea breath test) was measured in study visit 1(0 week) and visit 3(4 week).
次要结局
- Changes in subjects' symptoms(4 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
研究点 (1)
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