None listed
Conditions
Interventions
Medical Device : Treatment groups will receive acupuncture treatment 10 times for 4 weeks and control group will continue the usual care. The follow-up observation will be made in the 5th and 13th wee
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 19 to 65. 2. Those with unexplained fatigue whose symptom is continuous and repetitive for more than 6 months. 3. Those with no abnormal findings in BP, CBC (Hb, Hct, WBC, Glucose), biochemical examination (AST, ALT, and Creatinine), electrolyte (Na, K, Cl), TFT (TSH, FT4), pregnancy test (fertile woman), chest X-ray test, and ECG test. Abnormality criteria: DBP is 90mmHg or greater (after putting subjects at rest for more than 5 minutes, DBP was measured twice at an interval of 2 minutes or longer while they were seated and the results were averaged), Hb is smaller than 13g/dL and Hct is lower than 38% in case of a male adult while Hb is greater than 11.5g/dL and Hct is 36% or lower in case of a female adult, WBC is 11,000/mm3 or greater, random plasma glucose is 200mg/dL or greater, AST is 50 IU/L or greater and ALT is 50 IU/L or greater, Creatinine is 1.5mg/dL or greater, Na is smaller than 135mmol/L or 145mol/L or greater, K is smaller than 3.5mmol/L or 5.5mmol/L or greater, Cl is smaller than 97mmol/L or 110mmol/L or greater, TSH is smaller than 0.35mIU/mL or 5.50mIU/mL or greater, FT4 is smaller than 0.89ng/dL or 1.76ng/dL or greater, urine hCG is (+), lesions of pulmonary tuberculosis other than inactive tuberculosis in chest X-ray, and arrhythmia requiring treatment, ischemic heart disease, cardiomegaly etc. in ECG. 4. Those whose numeric rating scale score was at least 4 for the past week during their screening visit. 5. Those who consented to participation in this trial and signed an informed consent statement after listening to clear explanation of this clinical trial's purpose and characteristics.
Exclusion criteria
Exclusion criteria: 1.Those who have the following causes in their past history or history of present illness that may trigger chronic fatigue. a. Organic causes : acute, chronic liver disease (hepatitis, liver cirrhosis etc.), anemia, tuberculosis, chronic lung disease, cardiovascular disease (heart failure, hypertension etc.), endocrine/metabolic disease (diabetes, thyroid gland disease, severe obesity whose BMI is 45 or greater etc.), autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis etc.), malignant tumor, infectious disease etc. b. Psycho-social causes : depression, anxiety neurosis, recent severe stress, schizophrenia, alcoholism, diet disorder (anorexia nervosa, bulimia nervosa) etc. 2. Those who took the following drugs for the recent two weeks: antihypertensive drugs, antidepressants, antianxiety agent, hypnotics, antihistamines etc. 3. Pregnant, expecting pregnant or breast-feeding women. 4. Those who are participating in other clinical trials. 5. Those who are engaged in multiple business. 6. Those who have experienced hypersensitivity reaction after acupuncture treatment. 7. Those who are inmates at group facilities such as social welfare institutions. 8. Those who don't consent to an informed consent statement. 9. Others who clinical trial conductors consider inappropriate for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale score | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale score;Stress Response Inventory-short form score;Beck Depression Inventory score;Numeric Rating Scale score;EuroQol-5 Dimenstion (EQ-5D) score | — |
Countries
Korea, Republic of
Contacts
Public ContactKwon-Eui Hong
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed