None listed
Conditions
Interventions
None listed
Sponsors
Sangji University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults over 19 years 2) Those who satisfy the following 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 occurrence 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
Exclusion criteria
Exclusion criteria: (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) Orthodontic prostheses in the mouth (4) Smokers (5) Sleep apnea or narcolepsy (6) New drugs within one month (7) currently taking drugs cause fatigue or drowsiness (8) History of malignant tumors, chronic hepatitis, or liver cirrhosis (9) History of major depressive disorder, bipolar affective disorders, schizophrenia, dementia, anorexia nervosa, bulimia (10) History of chronic renal failure, tuberculosis, asthma, or multiple sclerosis (11) History of alcohol or other substance abuse from 2 years before the onset of fatigue into the time of screening (12) Myocardial infarction, Unstable angina pectoris, Stroke, Cerebral ischemic attack, heart failure, uncontrolled arrhythmia, and previous coronary revascularization (13) Severe metabolic disease / Cardiovascular, cerebrovascular disease / Any other diseases or disorders that may affect physical and mental fatigue/ systemic infectious disease requiring treatment (14) Uncontrolled hypertension (SBP >180mmHg or DBP >110 mmHg) or edema (15) BMI greater that 45 kg/m2 (16) Positive HBsAg, HCB-Ab, HIV test (17) Serum creatinine >UNL X 2 times (18) HbA1c > 9% (19) AST, ALT, or serum bilirubin >UNL X 2.5 times (20) TSH below 0.40 mIU/L or over 4.0 mIU/L (21) Currently receiving treatment to improve fatigue (22) Pregnant, lactating, or fertile women, or positive urine pregnancy test results (23) Participants in any other clinical studies within one month of screening (24) Anyone who is deemed unsuitable for other clinically significant medical or psychiatric findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Matching rate among classification categories according to the cut off point and expert judgement results | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate | — |
Countries
Korea, Republic of
Contacts
Public ContactUi Min Jerng
Sangji University Oriental Medical Center
Outcome results
None listed