KCT0002684
Active, not recruiting
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 sites96 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kyung Hee University Oriental Medicine Hospital at Gangdong
- Enrollment
- 96
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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