An interventional study of Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer in Functional Dyspepsia, sponsored by Wonju Severance Christian Hospital. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by Wonju Severance Christian Hospital · Not applicable, Interventional, and Treatment
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:
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.
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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 48 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Wonju Severance Christian Hospital is the lead sponsor of 41 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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.
Device: Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer
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.
Device: Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer
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.
Also known as: Purified water (PW) generated from sham device
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.
Time frame: 6 weeks
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.
Time frame: 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.
Time frame: 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
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Wonju Severance Christian Hospital