A Pilot Study of Drinking Electrolyzed Hydrogen-rich Alkaline Reduced Water Generated by Alkaline Ionizer (BTM-1200) on the Chronic Functional Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Complete spontaneous bowel movement (CSBM) frequency
研究概览
简要总结
The goal of this clinical trial is to investigate drinking effect of electrolyzed hydrogen-rich alkaline reduced water (EHARW) in chronic constipation patients. The main question is that drinking EHARW will improve the symptoms of chronic constipation for 4 weeks.
Participants will drink EHARW (20 mL/kg of body weight/day) generated from the experimental device for 4 weeks.
详细描述
Patients diagnosed with constipation will be recruited and screened according to the inclusion and exclusion criteria after sign in the informed consent form. The selected patients will be enrolled. The experimental device (BTM-1200, Bion-Tech, Gyeonggi-do, Korea) will be installed at each patient's house. The researcher will instruct patients drinking method. The patients will drink a total of 20 mL/kg of body weight/day of EHARW (pH 9.5) in 3-different times, and drink directly from the device on an empty stomach for 4 weeks. The clinical trial is conducted in a single group without a control group, and the efficacy is evaluated by comparing the symptoms of constipation pre- and post-intervention. The primary outcome is the proportion of responders based on frequency of complete complete spontaneous bowel movement (CSBM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No need of blinding
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
- 否
入选标准
- •Men and women aged 19 to 70 years old
- •Those who meet the criteria for Roma Ⅳ function constipation
- •Symptoms begin before 6 months and last for more than 3 months
- •Those who do not have organic lesions that may cause constipation
- •A patient who has personally signed the consent form
- •If all the criteria meet
排除标准
- •Those taking drugs such as opioid analgesics, antipsychotics, calcium blockers, and parasympathetic antagonists
- •Kidney disease (renal failure, potassium excretion disorder, etc.)
- •Patients with colon-related diseases (colon cancer, intestinal stenosis, rectal flow, anal fissure, rectal bleeding), diabetes, thyroid dysfunction, or anemia
- •Pregnant or lactating women
- •In addition to the above, those who are judged to be difficult to conduct research by the clinical trial director
- •Excluded if at least one of the above criteria meet
结局指标
主要结局
Complete spontaneous bowel movement (CSBM) frequency
时间窗: 4 weeks treatment
CSBM is used to access the frequency of bowel movement. This indicates the efficacy of EHARW (pH 9.5) after 4-weeks of treatment in chronic constipation patients.
次要结局
- Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire(4 weeks treatment)
- Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire(4 weeks treatment)
- Bristol stool scale score(4 weeks treatment)
研究者
Kyu Jae Lee
Professor
Wonju Severance Christian Hospital