Effectiveness and Safety of Electro-acupuncture for the Patients with Gastroesophageal Reflux Disease

Not Applicable

Recruiting

Conditions: Diseases of the digestive system

Registration Number: KCT0001653

Lead Sponsor: Kyung Hee University Oriental Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

(1) are aged between 19 and 75 years
(2) are diagnosed with GERD (including both erosive reflux disease and non-erosive reflux disease) within a year
(3) have one or more of following symptoms for a month recently
: heartburn, regurgitation, dyspepsia, epigastric pain, belching, nausea, globus (feeling of a lump in the esophagus), dysphagia, cough, hoarseness
(4) have symptoms stated above either with frequency for =4 days of mild symptom or = 2 days of moderate to severe symptom during last 7 days (mild: symptoms were easily tolerated, the discomfort was only minimal and did not affect normal activities; moderate: symptoms were sufficient to affect normal activities; severe: symptoms markedly affected normal activities) [25]
(5) have symptoms stated above despite the experience of standard treatment (pharmacological treatment or lifestyle modification) for GERD during 4 weeks within last one year.
(6) agree with participation in this study and sign a written informed consent voluntarily

Exclusion Criteria

(1) have structural disease, confirmed by esophagogastroduodenoscopy, related current symptoms (ex. gastrointestinal cancer, eosinophilic esophagitis, candida esophagitis, etc.).
(2) have alarm symptoms (severe dysphagia, hematemesis, weight loss, and hematochezia)
(3) have past history of gastrointestinal cancer within 5 years
(4) have received chemotherapy due to cancer within a month
(5) are diagnosed with ischemic heart disease (ex. angina pectoris, myocardial infarction)
(6) have artificial cardiac pacemaker in the chest
(7) experienced hypersensitivity reaction after acupuncture treatment or are not feasible person to take the acupuncture treatment
(8) are taking part in the other clinical trial which might affect the result of this trial or taking Korean medical treatment related GERD; minimum wash-out period of two weeks is required before participating in the trial
(9) Individuals who have difficulties in attending the trial (e.g serious mental illness, dementia, drug addiction, severe disorder in vision or hearing, illiteracy, and time constraint etc.)
(10) are pregnant or breastfeeding

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of responders (PR)

Secondary Outcome Measures

Name	Time	Method
epean Dyspepsia Index - Korean version (NDI-K);gastrointestinal hormone(Gastrin, Motilin);Inflammatory mediator cytokine (IL-1, IL-6, IL-8, IL-4, and IL-10 );EuroQol-5 Dimension (EQ-5D);Korean Gastrointestinal Symptom rating scale (KGSRS) ;11 point Numerical Rating Scale (NRS);Perceived Stress Scale (PSS);Blinding Index & Credibility assessment ;Pattern Identification for Gastroesophageal Reflux Disease (PIGERD);The Acupuncture Beliefs Scale;Patient Global Impression of Change (PGIC);Qi-stagnation questionnaire;Spleen Qi Deficiency Questionnaire;Evaluation of rescue medicine;adverse events