Back to resultsDrinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation
Primary Purpose
Chronic Constipation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electrolyzed Alkaline Ionizer
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Constipation focused on measuring constipation, hydrogen-rich alkaline ionized water, complete spontaneous bowel movement, patient assessment of constipation-symptoms, patient assessment of constipation-quality of life
Eligibility Criteria
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
Sites / Locations
- Wonju College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EHARW Treatment group
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Bristol stool scale score
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.
Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire
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
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.
Full Information
NCT ID
NCT05734859
First Posted
January 26, 2023
Last Updated
March 29, 2023
Sponsor
Wonju Severance Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05734859
Brief Title
Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation
Official Title
A Pilot Study of Drinking Electrolyzed Hydrogen-rich Alkaline Reduced Water Generated by Alkaline Ionizer (BTM-1200) on the Chronic Functional Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonju Severance Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
comparison between baseline and post-treatment in single group
Masking
None (Open Label)
Masking Description
No need of blinding
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EHARW Treatment group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Electrolyzed Alkaline Ionizer
Other Intervention Name(s)
BTM-1200
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete spontaneous bowel movement (CSBM) frequency
Description
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.
Time Frame
4 weeks treatment
Secondary Outcome Measure Information:
Title
Bristol stool scale score
Description
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.
Time Frame
4 weeks treatment
Title
Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire
Description
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.
Time Frame
4 weeks treatment
Title
Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire
Description
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.
Time Frame
4 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Jae Lee, Ph.D.
Organizational Affiliation
Department of Convergence Medicine, Wonju College of Medicine, Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonju College of Medicine
City
Wonju
State/Province
Ganwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation
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