Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation

NCT05734859 | Completed

• 1 other identifier: EMB-2022-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Constipation

Keywords

constipation; hydrogen-rich alkaline ionized water; complete spontaneous bowel movement; patient assessment of constipation-symptoms; patient assessment of constipation-quality of life

Outcome Measures

Primary Outcomes (1)

• Complete spontaneous bowel movement (CSBM) frequency

  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.

  4 weeks treatment

Secondary Outcomes (3)

• Bristol stool scale score

  4 weeks treatment

• Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire

  4 weeks treatment

• Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire

  4 weeks treatment

Study Arms (1)

EHARW Treatment group

EXPERIMENTAL

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.

Device: Electrolyzed Alkaline Ionizer

Interventions

Electrolyzed Alkaline Ionizer DEVICE

Patients will drink EHARW calculated by 20 mL/kg body weight/day which can be divided into several times a day for drinking. The patient is recommended to drink water in an empty stomach and to drink water generated from the device as soon as possible.

Also known as: BTM-1200

EHARW Treatment group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Wonju College of Medicine

Wŏnju, Ganwon-do, 26426, South Korea

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyu-Jae Lee, Ph.D.

  Department of Convergence Medicine, Wonju College of Medicine, Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No need of blinding
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: comparison between baseline and post-treatment in single group

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 21, 2023
• Study Start: November 30, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)