Tongue diagnosis of Chronic Fatigue Patients and Healthy Control Subjects : A Cross-sectional Study Ver1.1
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0004011
- Lead Sponsor
- Sangji University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 138
1) Adults over 19 years
2) Those who satisfy the follwoing three conditions of 'Modified 1994 research case definition criteria for chronic fatigue syndrome worksheet'
? Clinically evaluated, unexplained, persistent or relapsing chronic fatigue that is of new or definite onset
? The concurrent occurence of four or more of the following symptoms, all of which must have persisted or recurred during 6 or more consecutive months of illness and must not have predated the fatigue
? Exclusion of other clinical causes that may explain fatigue in health screening after the onset
(1) Those who can not open their mouths due to jaw joint disorders
(2) Glossities, Anatomical abnormality on the tongue, or intraoral bleeding disorders
(3) Smokers
(4) Myocardial infarction, Unstable ngina pectoris, Stroke, Cerebral ischemic attack, heart failure, incontrolled arrhythmia, and previous coronary revascularization
(5) Severe metabolic disease / Cardiovascular, cerebrovascular disease / Any other diseases or disorders that may affect physical and mental fatigue/ systemic infectious diease requiring treatment
(6) Current taking medication or vitamins
(7) AST, ALT, or serum bilirubin >UNL X 2.5 times, or drug-induced / alcoholic hepatitis, liver cirrhosis, fatty liver requiring treatment
(8) Positive HBsAg, HCB-Ab, HIV test
(9) Serum creatinine >UNL X 2 times, or chronic renal failure or any other renal diseases requiring dialysis
(10) Uncontrolled diabetes (HbA1c > 9%)
(11) Uncontrolled hypertension (SBP >180mmHg or DBP >110 mmHg) or edema
(12) History of malignant tumors within the past 5 years
(13) Tuberculosis, Multiple sclerosis, hypothyroidism, uncontrolled asthma
(14) Bipolar affective disorders, schizophrenia, dementia, delusional disorder
(15) History of Anorexia or bulimia or suspected anorexia/bulimia
(16) BMI greater that 45 kg/m2
(17) Orthodontic prostheses in the mouoth
(18) Pregnant, lactating, or fertile women, or positive urine pregnancy test results
(19) Participants in any other clinical studies within one month of screening
(20) Anyone who is deemed unsuitable for ohter clinically significnat medical or psychiatric findings
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of coated tongue
- Secondary Outcome Measures
Name Time Method Weight of coated tongue;Color of dorsal part of tongue (Total area / Area with no coated tongue / Area with coated tongue);Fatigue Severity Scale (FSS);Pittsburgh Sleep Quality Index (PSQI)