KCT0002684进行中（未招募）未知
Investigator Initiated Trial to evaluate the safety and efficacy of Sipgeondaebotang in Chronic Fatigue Syndrome
Kyung Hee University Oriental Medicine Hospital at Gangdong0 个研究点目标入组 96 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
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) who decided to participate voluntarily, after understanding the detailed explanation of the clinical trial
- •2) aged between 19 and 65
- •3) The total score of CIS(Checklist Individual Strength) exceeds 76
- •4) Clinically evaluated, unexplained, persistent or relapsing chronic fatigue that satisfies below 3 contents (following the guidelines of CDC(Center for Disease Control and Prevention) in the United States, 1994): 1) Is not the result of ongoing exertion and is not substantially alleviated by rest 2) Results in substantial reduction in previous levels of occupational, educational, social, or personal activities 3) More than 4 of the following symptoms: self-reported impairment in short-term memory or concentration severe enough to cause substantial reduction in previous levels of occupational, educational, social, or personal activities; sore throat; tender cervical or axillary lymph nodes; muscle pain; multi-joint pain without joint swelling or redness; headaches of a new type, pattern, or severity; unrefreshing sleep; post-exertional malaise lasting more than 24 hours
排除标准
- •1) With medical history of hypersensitivity to the test drug or other herbal ingredients
- •2) If anorexia or bulimia are suspected or have a past history
- •3) With a BMI greater than 45 kg/m2
- •4) With AST or ALT or serum bilirubin > UNL X 2 times, or toxic/alcoholic hepatitis, liver cirrhosis, or fatty liver in need of medical attention
- •5) HBsAg, HCV-Ab, or HIV test is positive
- •6) Serum creatinine > UNL X 2 times, or chronic renal failure or renal disease patient requiring dialysis
- •7) Hypertension which is uncontrolled (SBP > 180 mmHg or DBP > 110 mmHg) or edematous patient
- •8) Unregulated diabetes mellitus (HbA1c > 9%)
- •9) With previous medical history of malignant tumors within the past 5 years
- •10) Tuberculosis, multiple sclerosis, hypothyroidism, asthma uncontrolled by drug
- •11) major depressive disorder, bipolar affective disorder, schizophrenia, dementia, delusional disorder
- •12) Clinically significant gastrointestinal disease patients that may affect drug absorption, distribution, metabolism, and excretion
- •13) Patients with myocardial infarction, unstable angina pectoris, stroke, cerebral ischemic attack, heart failure(NYHA ?, ?), uncontrolled arrhythmia, or coronary revascularization procedure within 6 months before screening
- •14) Several diseases which the examiner determines to have a clinically significant effect on trial, such as the severe metabolic disease, cardiovascular disease, cerebrovascular disease, disease or disorder that may affect physical and mental fatigue, or systemic infectious disease requiring treatment
- •15) Who are scheduled to exercise therapy (doctor's exercise prescription) during the trial period
- •16) Women who is pregnant, may be pregnant, or is lactating
- •17) Women of childbearing age with a positive pregnancy test (using ß-hCG serum or urine) within 28 days before the treatment or refusing to use the contraception during the trial period (Women who have a record of menopause (defined as abnormal amenorrhea more than a year) or surgical sterilization before screening are excluded from women of childbearing age)
- •18) Alcohol abuse or other drug abuse history within a year before screening
- •19) Who participated in other clinical trials within 3 months before screening (Definition of participation” is based on the final administration date of the clinical trial drug)
- •20) Any person who is deemed inadequate by the examiner due to other clinically significant medical or psychiatric findings
研究者
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