Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a pilot randomized controlled trial

Korea Institute of Oriental Medicine0 个研究点目标入组 24 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Males and females aged 19 to 65
•2. Those with unexplained fatigue whose symptom is continuous and repetitive.
•3. Those with no abnormal findings in BP, CBC (Hb, Hct, WBC, Glucose), biochemical examination (AST, ALT, and Creatinine), TFT (TSH, FT4), urinalysis (urine glucose and urine protein), 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 39% in case of a male adult while Hb is greater than 12g/dL and Hct is 36% or lower in case of a female adult, WBC is smaller than 4,500/ mm3 or 11,000/mm3 or greater, Glucose is 100mg/dL or greater, AST is 40 IU/L or greater and ALT is 40 IU/L or greater, Creatinine is 1.5mg/dL or greater, TSH is smaller than 0.27mIU/mL or 4.2mIU/mL or greater, TSH is smaller than 0.27mIU/mL or 4.2mIU/mL or greater, FT4 is smaller than 0.93ng/dL or 1.7ng/dL or greater, FT4 is smaller than 0.93ng/dL or 1.7ng/dL or greater, In urinalysis, urine glucose is (+) or greater and urine protein (+) or greater in urinalysis, and lesions of pulmonary tuberculosis other than inactive tuberculosis in chest X-ray.
•4. 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.

•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, thyroind gland disease, severe obesity whose BMI is 45 or greater 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. Patients who have used medical and alternative treatment for chronic fatigue during last 1 month.
•5. Those who have participated in other clinical trials during the past 6 months.
•6. Those who are night shift workers, shiftworkers, or engaged in multiple business.
•7. Those who have experienced hypersensitivity reaction after acupuncture treatment.
•8. Those who are inmates at group facilities such as social welfare institutions.
•9. Those who don't consent to an informed consent statement.
•10. Others who clinical trial conductors consider inappropriate for participating in this trial.

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