The influence of patient-clinician interaction context on acupuncture outcomes in functional dyspepsia
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002229
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 59
(1) Age between 20 and 65 years
(2) Meeting the definition of Functional Dyspepsia(FD) and Postprandial distress syndrome (PDS) as a subtype of Functional Dyspepsia according to the Rome III criteria
(3) Complaints of a degree of dyspepsia more than 40 points on the visual analogue scale (VAS; 0, no symptom at all; 100, the most severe symptom one has ever had)
(4) Individuals who agreed not to take any other new treatments associated with Functional Dyspepsia during the study
(5) Individuals who voluntarily agreed and singed informed consent form
(1) Have abnormal esophagogastroduodenoscopy results recently or evidence of any organic diseases affecting gastrointestinal tract (e.g. erosive esophagitis, peptic ulcer, dysplasia, mucosa-associated, lymphoid tissue lymphoma, esophageal cancer, gastric cancer)
(2) Individuals who have apparent signs of irritable bowel syndrome
(3) Individuals who have alarmingsymptoms (weight loss, black or tarry stool, or dysphagia)
(4) Individuals who have serious structural organ diseases (diseases of the heart, lung, liver, or kidney) or mental illness
(5) Individuals who have undergone surgery related to the gastrointestinal tract (except for appendectomy performed for more than 6 months ago)
(6) Individuals who are pregnant or breastfeeding
(7) Individuals who are taking drugs that could affect the gastrointestinal tract ; a minimum wash-out period of 2 weeks is required before participating in the trial.
(8) Individuals who have participated other clinical trial within 1 month from the present
(9) Individuals who are positive for human immunodeficiency virus infection
(10) Individuals who are taking herbal medicine or oriental remedy that associated with dyspepsia / drugs that are considered inappropriate for this study
(11) Difficulties in attending the trial (e.g., paralysis, serious mental illness, dementia, drug addiction, time constraints, severe disorder of vision or hearing, illiteracy, etc.)
** Patients who have severe depression will be excluded from the study (One who has more than 24 points in Beck Depression Inventory) [12].
(12) Individuals with other issues that could interfere with acupuncture treatment (e.g., clotting disorders or leukopenia, a pacemaker, epilepsy, or anticoagulant therapy)
** To exclude patients with severe organic disease, following blood and urine test will be performed at screening visit: Complete Blood Count (White Blood Cell, Hemoglobin, Hematocrit, Platelet), Liver Function Test (AST, ALT, rGT), Renal Function Test (BUN, Creatinine), ESR, Cholesterol (Total Cholesterol, HDL Cholesterol, LDL Cholesterol, TG), Glucose, Routine Urine Analysis
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Responder
- Secondary Outcome Measures
Name Time Method epean Dyspepsia Index – Korean version (NDI-K);Short Form 36-item Health Survey (SF-36);State-Trait Anxiety Inventory (STAI) questionnaire ;Visual analog scale (VAS) for dyspepsia;Expectations for relief scale;Massachusetts general hospital acupuncture Sensation Scale (MASS);The Consultation and Relational Empathy (CARE) Measure;Interpersonal Reactivity Index (IRI);Maximum tolerable volume (MTV);The Pictorial Representation of Illness and Self Measure (PRISM)