Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 8:31 PM
Study NCT ID:
NCT05693259
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer
Sponsor:
Wonju Severance Christian Hospital
Organization:
Study Overview
Official Title:
Improvement Effect of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer in Functional Ddyspepsia Patients
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: