Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Changes in Erosions
研究概览
简要总结
The investigators performed a double-blind parallel study in a group of Subjects Showing Erosive Gastritis who were given Hizikia Fusiformis Extract over a period of 4 weeks. Endoscopic observations were performed before and 4 weeks after the treatment, and the cure and improvement rates were investigated.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 19-70 years old
- •Subjects Showing Erosive Gastritis (endoscopy)
- •Able to give informed consent
排除标准
- •Diagnosed of gastrointestinal disease such as ulcer, cancer within 1 months
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
- •Taken antibiotics and stomach medicines such as steroid, bismuth compound and proton pump inhibitor within 1 months
- •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
Hizikia Fusiformis extract
干预措施: Hizikia Fusiformis extract (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in Erosions
时间窗: 4 weeks
Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.
Changes in Score of Erosions
时间窗: 4 weeks
Score of erosions(score 1-4) was measured in study visit 1(0 week) and visit 3(4 week). Score of erosions is assigned a score of between 1 (Erosion = 0) to 4 (Erosion ≥ 6) and summed to form a score ranging from 1 (best) to 4 (worst).
次要结局
- Changes in PepsinogenⅠ(4 weeks)
- Changes in Gastrin(4 weeks)
- Changes in Pepsinogen Ⅰ/Ⅱ Ratio(4 weeks)
- Changes in Subjects' Symptoms Total Score(4 weeks)
- Changes in Hs-CRP(High Sensitivity C-reactive Protein)(4 weeks)
- Changes in PepsinogenⅡ(4 weeks)
研究者
Soo-Wan Chae
Principal Investigator
Chonbuk National University Hospital