The evaluation of safety and efficacy of Sipgeondaebotang in Chronic Fatigue Syndrome

Not Applicable

Active, not recruiting

• Conditions: Symptoms, signs and abnormal clinical and laboratory findings, NEC

• Registration Number: KCT0002684
• Lead Sponsor: Kyung Hee University Oriental Medicine Hospital at Gangdong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 December 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 96

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
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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects who had a CIS(Checklist Individual Strength) total score of 76 or less after 8 weeks of medication administration