Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation

Wonju Severance Christian Hospital

Status: Completed

Conditions: Chronic Constipation

Treatments: Device: Electrolyzed Alkaline Ionizer

Study type: Interventional

Funder types: Other

Identifiers

NCT05734859

EMB-2022-03

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

EHARW Treatment group

Experimental group

Description:

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.

Treatment:

Device: Electrolyzed Alkaline Ionizer