Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation
- Conditions
- Chronic Constipation
- Interventions
- Device: Electrolyzed Alkaline Ionizer
- Registration Number
- NCT05734859
- Lead Sponsor
- Wonju Severance Christian Hospital
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EHARW Treatment group Electrolyzed Alkaline Ionizer The experimental group will drink a total amount of 20 mL/ kg body weight/day of EHARW for 4 weeks on an empty stomach according to the researcher's instruction.
- Primary Outcome Measures
Name Time Method Complete spontaneous bowel movement (CSBM) frequency 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.
- Secondary Outcome Measures
Name Time Method Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire 4 weeks treatment PAC-SYM is used to access constipation symptoms of patient before and after the intervention. This tool is categorized into 3 (abdominal, rectal, stool), and includes total 12 questions. Higher score present improvement of constipation symptoms.
Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire 4 weeks treatment PAC-QOL is used to access constipation-related quality of life before and after the intervention. This tool is categorized into 4: physical discomfort, psychological discomfort, worries and satisfaction, and consists of 28 questions. Higher score present improvement of constipation symptoms.
Bristol stool scale score 4 weeks treatment Fecal form is accessed by using Bristol stool scale. Fecal form indicate hardness of stool. Higher score present improvement of constipation symptoms. Similarly other questionnaires using self observation diary was also assessed including straining at defecation, stiffness of the stool, sensation of incomplete evacuation, and sensation of obstruction.
Trial Locations
- Locations (1)
Wonju College of Medicine
🇰🇷Wonju, Ganwon-do, Korea, Republic of