Functional DyspepsiaNCT05693259
Improvement of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer
A study testing Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer in people with Functional Dyspepsia, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2022to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
This study was designed as a randomized, parallel, double-blind controlled clinical trial. Enrolled patients with FD will be allocated randomly into two groups: EARW group and PW group. For 6 weeks, the patients will drink EARW and PW (10mL/kg/day body weight) in empty stomach condition. For the primary outcome measure, the gastrointestinal symptom rating scale (GSRS) will be used, and for the secondary outcome measure functional dyspepsia-related quality of life (FD-QoL), and Korean version of the Nepean Dyspepsia Index (NDI-K) will be used at baseline and at 6 weeks.
- Conditions
- Functional Dyspepsia
- Being tested
- Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizerDevice
Also called Purified water (PW) generated from sham device
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.
| Study group | Role | What they receive |
|---|---|---|
| EARW group | Experimental | 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. Receives: Device: Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer |
| PW group | Sham comparator | 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. Receives: Device: Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastrointestinal symptom rating scale (GSRS)
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.
Measured: 6 weeks
Secondary outcomes (3)
functional dyspepsia-related quality of life (FD-QoL),
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.
Measured: 6 weeks
Korean version of the Nepean Dyspepsia Index (NDI-K)
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.
Measured: 6 weeks
Inflammatory cytokines
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start10 Aug 2022
- Primary completion28 Oct 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Control group (PW): purified water-drinking group * Experimental group (EARW): Electrolyzed alkaline reduced water drinking group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Jae Lee, Wonju Severance Christian Hospital
- Investigators
- Kyu-Jae Lee, Ph.D., Study chair, 20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693259
- Sponsor's protocol ID
- EMB-2022-01
- Status last verified
- Jan 2023
- First submitted
- 8 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement Effect of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer in Functional Ddyspepsia Patients
- ClinicalTrials.gov ID
- NCT05693259
- Acronym / sponsor ID
- EMB-2022-01
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was designed as a randomized, parallel, double-blind controlled clinical trial. Enrolled patients with FD will be allocated randomly into two groups: EARW group and PW group. For 6 weeks, the patients will drink EARW and PW (10mL/kg/day body weight) in empty stomach condition. For the primary outcome measure, the gastrointestinal symptom rating scale (GSRS) will be used, and for the secondary outcome measure functional dyspepsia-related quality of life (FD-QoL), and Korean version of the Nepean Dyspepsia Index (NDI-K) will be used at baseline and at 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- * Control group (PW): purified water-drinking group * Experimental group (EARW): Electrolyzed alkaline reduced water drinking group
| Arm | Type | Receives |
|---|---|---|
| EARW group | Experimental | Device: Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizerPatients 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. |
| PW group | Sham comparator | Device: Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizerPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Subjects who have a history of serious malignancy including gastrointestinal malignancy, cerebrovascular disease, and heart disease within the past 6 months were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizerAlso: Purified water (PW) generated from sham devicePatient 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. | Device | EARW group, PW group |
Primary outcome
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.
3 secondary outcomes
functional dyspepsia-related quality of life (FD-QoL),
Time frame: 6 weeks
Korean version of the Nepean Dyspepsia Index (NDI-K)
Time frame: 6 weeks
Inflammatory cytokines
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Jae Lee, Ph.D. study chair
20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer in people with Functional Dyspepsia, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal symptom rating scale (GSRS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.