- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05693259
Improvement of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer
Improvement Effect of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer in Functional Ddyspepsia Patients
The goal of this clinical trial is to evaluate the effect of drinking electrolyzed alkaline reduced water (EARW) compared to drinking purified water (PW) on functional dyspepsia (FD) patients.
The main question[s] it aims to answer are:
- Drinking EARW (EARW group) will alleviate gastrointestinal (GI) symptoms and FD symptoms compared to drinking PW (PW group).
- Drinking EARW will make higher the FD-related Quality of Life (FD-QOL) compared to drinking PW.
Patients will drink EARW 10mL/kg/day body weight for 6 weeks according to the instruction of researcher using the experimental device installed at each patient's house. After 6 week, EARW and PW groups will be compared to evaluate effect of GI symptom and FD-related QOL.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gwando
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Wonju, Gwando, Korea, Republic of, 26426
- Wonju Severance Christian Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Symptoms onset should start at least 6 months before diagnosis based on one or more of the following symptoms Rome IV criteria (Unpleasant postprandial fullness, early satiety, epigastric pain, epigastric burning sensation)
- No evidence of structural disease in gastroscopy within the last 3 months
- Aged 19-70 years
- Who meets Rome IV criteria for functional dyspepsia
- Who have 4 or more symptoms based on the gastrointestinal symptom rating scale
- Patients who voluntarily agree to participate in this study and sign a written consent
Exclusion Criteria:
Subjects who have a history of serious malignancy including gastrointestinal malignancy, cerebrovascular disease, and heart disease within the past 6 months were excluded
- Subjects who have uncontrolled diabetes and hypertension despite appropriate management
- Subjects who have a history of peptic ulcer or reflux esophagitis within the past 6 months were excluded
- Subject who have history of gastrointestinal surgery were excluded
- Women who are pregnant or breastfeeding
- Subjects who are taking drugs that may affect the gastrointestinal tract (minimum of 2 weeks washout period is necessary before participating in the trial (Medications include H2 receptor blockers, anticholinergics, prostaglandins, proton pump inhibitors, gastromucosal protection agents, corticosteroids, non-steroidal anti-inflammatory drugs, aspirin, mucosal protective agents, etc.)
- Subjects who are under drugs for therapeutic purposes such as functional food that promotes gastric health
- Subjects who consumed more than 14 times alcohol per week in case of man and 7 times per week in case of female in the past 1 month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EARW group
Patients in EARW group drink EARW (pH 9.5) 10 mL/kg body weight per a day using experimental device installed in the house for 6 weeks.
We recommend to drink water in empty stomach three or four times a day.
The water generated from device will be administered immediately, not to be stored.
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Patient will be allocated randomly to two groups: EARW and PW groups.
For 6 weeks, patients drink water (10mL/kg body weight/day ) generated from the device installed in the house before starting intervention.
Patients will be instructed to drink in empty stomach, and to drink immediately after generation of water.
The total amount that the patient drank the day before will be monitored by a researcher using survey form of mobile phone everyday.
Other Names:
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Sham Comparator: PW group
Patients in PW group drink PW (pH 9.5) 10 mL/kg body weight per a day using Sham device installed in the house for 6 weeks.
We recommend to drink water in empty stomach three or four times a day.
The water generated from device will be administered immediately, not to be stored.
Sham device was built in the same shape and operation as the experimental device.
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Patient will be allocated randomly to two groups: EARW and PW groups.
For 6 weeks, patients drink water (10mL/kg body weight/day ) generated from the device installed in the house before starting intervention.
Patients will be instructed to drink in empty stomach, and to drink immediately after generation of water.
The total amount that the patient drank the day before will be monitored by a researcher using survey form of mobile phone everyday.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gastrointestinal symptom rating scale (GSRS)
Time Frame: 6 weeks
|
The GSRS is a survey questionnaire designed to assess the symptoms associated with common GI disorders.
It includes 15 questions on a scale of 1-7 that assess the inconvenience of the symptoms over the preceding period.
A higher GSRS score indicates more inconvenient symptoms.
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional dyspepsia-related quality of life (FD-QoL),
Time Frame: 6 weeks
|
The FD-QoL questionnaire was used to measure the quality of life of FD patients.
It includes total 21 items, and is categorized into 4: eating/diet (five items), daily activity (four items), emotion (six items), and social functioning (six items) on a 5-point Likert scale.
A higher score indicates worse QoL.
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6 weeks
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Korean version of the Nepean Dyspepsia Index (NDI-K)
Time Frame: 6 weeks
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The NDI-K is a validated tool used for evaluating clinically meaningful FD changes, symptoms related to gastrointestinal problems.
and it includes 15 symptom-based questions.
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6 weeks
|
Inflammatory cytokines
Time Frame: 6 weeks
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Interleukin (IL)-1β, IL-10, IL-6, tumor necrosis factor (TNF)-α, and interferon gamma (IFN-γ) levels were measured to observe inflammatory immune response
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6 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Kyu-Jae Lee, Ph.D., 20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMB-2022-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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