Feasibility of quantitative measurement of several components in abdominal examination - for functional dyspepsia
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002450
- Lead Sponsor
- Kyung Hee University Oriental Medicine Hospital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 88
1. Patient inclusion criteria
1) Subjects between the ages of 20 and 65 years;
2) Subjects who meet functional dyspepsia (FD) definition of Rome ? criteria;
2-1) Subjects with one or more of these symptoms (such as postprandial fullness, early satiation, or epigastric pain or burning) will be considered patients with dyspepsia,
2-2) and without organic disease basis that can explain symptoms,
2-3) have undergone the above symptoms for a minimum of three months from at least six months ago to the present time.
2. Control inclusion criteria
1) Subjects who have no problem communication;
2) Subjects who check less than 20 mm visual analogue scale for dyspeptic symptoms;
3) Subjects who have not gastrointestinal disorder and symptoms;
4) Subjects who have not serious structural diseases (disease of liver, heart, lung, or kidney);
5) Subjects who have normal laboratory test result.
1) Subjects who have organic disease such as peptic ulcer or gastroesophageal reflux disease go through esophagogastroduodenoscopy and laboratory test;
2) Subjects who have obvious signs of irritable bowel syndrome (IBS);
3) Subjects who have alarm symptoms (e.g., weight loss, black or tar stool, or dysphagia);
4) Subjects who have serious structural disease (e.g., disease of heart, lung, liver or kidney) or mental illness;
5) Subjects who have had surgery related with the gastrointestinal tract, except for appendectomy more than six months ago;
6) Subjects who are pregnant or breastfeeding;
7) Subjects who have taken any other clinical trial within 1 months;
8) Subjects who are human immunodeficiency virus (HIV) positive;
9) Subjects who have difficulty in attending the trial (e.g., paralysis, severe mental or psychological abnormality, dementia, drug addiction, time constraint, severe disorder in vision or hearing, outpatient treatment impossibility, illiteracy).
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation coefficient of five parameters of abdominal diagnosis
- Secondary Outcome Measures
Name Time Method Reliability, validity and optimal cut-off value between Korean medical doctors' diagnosis and obtained results using devices;Pattern identification questionnaires scores;Nepean Dyspepsia Index-Korean version score;Repulsive force and press depth on the acupoint using digital algometer;Oral temperature and thermal result of digital infrared thermal imaging;Measured bowel sound and frequency on abdomen;Measured impedance on acupoint of abdomen;Gastric emptying test;Pressure pain threshold on the acupoint using digital algometer;Tongue image