Improvement of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer
Functional Dyspepsia
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility Criteria
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
Sites / Locations
- Wonju Severance Christian Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
EARW group
PW 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.
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.