KCT0000508已完成未知
Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multi-center randomized controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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