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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Wonju Severance Christian Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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. 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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-10
• Primary completion: 2022-10-28
• Completion: 2022-11-29
• First posted: 2023-01-20
• Last updated: 2023-01-20

Locations

1 site across 1 country: South Korea