KCT0001653
Recruiting
未知
Effectiveness and Safety of Electro-acupuncture for the Patients with Gastroesophageal Reflux Disease: A Randomized, Patient and Assessor-blinded, Sham-controlled Clinical Trial
Kyung Hee University Oriental Medical Center0 sites60 target enrollmentTBD
ConditionsDiseases of the digestive system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the digestive system
- Sponsor
- Kyung Hee University Oriental Medical Center
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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