Improvement Effect of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer in Functional Ddyspepsia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- gastrointestinal symptom rating scale (GSRS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of drinking electrolyzed alkaline reduced water (EARW) compared to drinking purified water (PW) on functional dyspepsia (FD) patients.
The main question[s] it aims to answer are:
- Drinking EARW (EARW group) will alleviate gastrointestinal (GI) symptoms and FD symptoms compared to drinking PW (PW group).
- Drinking EARW will make higher the FD-related Quality of Life (FD-QOL) compared to drinking PW.
Patients will drink EARW 10mL/kg/day body weight for 6 weeks according to the instruction of researcher using the experimental device installed at each patient's house. After 6 week, EARW and PW groups will be compared to evaluate effect of GI symptom and FD-related QOL.
详细描述
This study was designed as a randomized, parallel, double-blind controlled clinical trial. Enrolled patients with FD will be allocated randomly into two groups: EARW group and PW group. For 6 weeks, the patients will drink EARW and PW (10mL/kg/day body weight) in empty stomach condition. For the primary outcome measure, the gastrointestinal symptom rating scale (GSRS) will be used, and for the secondary outcome measure functional dyspepsia-related quality of life (FD-QoL), and Korean version of the Nepean Dyspepsia Index (NDI-K) will be used at baseline and at 6 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
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms onset should start at least 6 months before diagnosis based on one or more of the following symptoms Rome IV criteria (Unpleasant postprandial fullness, early satiety, epigastric pain, epigastric burning sensation)
- •No evidence of structural disease in gastroscopy within the last 3 months
- •Aged 19-70 years
- •Who meets Rome IV criteria for functional dyspepsia
- •Who have 4 or more symptoms based on the gastrointestinal symptom rating scale
- •Patients who voluntarily agree to participate in this study and sign a written consent
排除标准
- •Subjects who have a history of serious malignancy including gastrointestinal malignancy, cerebrovascular disease, and heart disease within the past 6 months were excluded
- •Subjects who have uncontrolled diabetes and hypertension despite appropriate management
- •Subjects who have a history of peptic ulcer or reflux esophagitis within the past 6 months were excluded
- •Subject who have history of gastrointestinal surgery were excluded
- •Women who are pregnant or breastfeeding
- •Subjects who are taking drugs that may affect the gastrointestinal tract (minimum of 2 weeks washout period is necessary before participating in the trial (Medications include H2 receptor blockers, anticholinergics, prostaglandins, proton pump inhibitors, gastromucosal protection agents, corticosteroids, non-steroidal anti-inflammatory drugs, aspirin, mucosal protective agents, etc.)
- •Subjects who are under drugs for therapeutic purposes such as functional food that promotes gastric health
- •Subjects who consumed more than 14 times alcohol per week in case of man and 7 times per week in case of female in the past 1 month
结局指标
主要结局
gastrointestinal symptom rating scale (GSRS)
时间窗: 6 weeks
The GSRS is a survey questionnaire designed to assess the symptoms associated with common GI disorders. It includes 15 questions on a scale of 1-7 that assess the inconvenience of the symptoms over the preceding period. A higher GSRS score indicates more inconvenient symptoms.
次要结局
- functional dyspepsia-related quality of life (FD-QoL),(6 weeks)
- Inflammatory cytokines(6 weeks)
- Korean version of the Nepean Dyspepsia Index (NDI-K)(6 weeks)
研究者
Kyu Jae Lee
Professor
Wonju Severance Christian Hospital