Efficacy and Safety of Gongjindan and Ssanghwa-tang for Chronic Fatigue in Patients: Randomized, Double-blind, Placebo-Controlled, Clinical Trial
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0007515
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
1) Adult men and women between the ages of 19 and 65
2) Those with fatigue of unknown cause that appeared continuously or repeatedly for more than 6 months as the main symptom, with an average score of 4 or higher on the Korean version of the Fatigue Severity Scale (FSS)
3) Those who do not have abnormal findings that may cause fatigue on Blood pressure test, complete blood tests (Hb, Hct, WBC), biochemical tests (AST, ALT, creatinine, glucose), thyroid function tests (TSH, FT4), electrocardiograms.
4) Those who consented to participate and voluntarily signed the consent form after hearing a clear explanation of the purpose and characteristics of this clinical trial
5) Those who can communicate well with the investigator and fill out a questionnaire
6) Those who can be followed up during the clinical trial period
1) Those with a total score of 7 or more in FSS questions 4 and 9
2) Pregnant or lactating women or men and women of childbearing potential who do not agree to use a medically accepted method of contraception during clinical trials†
†Hormonal contraception, intrauterine device(Intrauterine device or Intrauterine system), tubal ligation, double blocking method (combined use of blocking methods such as male condom, female condom, cervical cap, contraceptive diaphragm, contraceptive sponge), single blocking method using spermicide
3) patients with uncontrolled hypertension (Diastolic Blood Pressure > 100mmHg or Systolic Blood Pressure > 160mmHg)
4) Those whose AST (Aspartate aminotranferase) or ALT (Alanine aminotransferase) or ALP (Alkaline phosphatase) exceeds 2.5 times the normal upper limit of the implementing institution
5) Those whose Creatinine exceeds 1.5 times the normal upper limit of the implementing institution
6) Those who have participated in another clinical trial within one month of the start of this trial or who plan to participate in another clinical trial during the trial period
7) Those with a history of hypersensitivity or allergy to the ingredients of clinical investigational drugs
8) Those with autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.)
9) Those with alcoholism, mental illness (sleep disorder, depression, anxiety neurosis), or drug dependence
10) Those with cognitive impairment or psychiatric problems
11) Those who underwent surgery within 2 weeks prior to the screening visit
12) Those who have received medical or oriental medical treatment for chronic fatigue within the last 2 weeks or have taken health functional foods(extract powder of Hovenia dulcis Thunb, fermented amino acid complex, extract of fermented porcine placenta, Prunus mume extracts, Ginseng extracts, Red Ginseng extracts, Rhodiola sachalinensis extracts) that help improve fatigue
13) Those who can recover from fatigue when living environment changes, such as those who work continuously at night or shift work
14) Those who are taking antidepressants, anti-anxiety drugs, or antihistamines at the screening visit
15) Those with other medical conditions that are judged to affect the test results or who are judged inappropriate by the investigator to participate in the trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in FSS score at Visit 4 compared to Visit 2 (basic visit)
- Secondary Outcome Measures
Name Time Method Change in FSS score at Visit 5 compared to Visit 2 (basic visit);Changes in the score of MFI-20, CFQ, SF-36 and SOFA/GP at visits 4 and 5 compared to visit 2 (basic visit);Changes in glucose, lactate, ammonia, and free fatty acid at visits 4 and 5 compared to visit 2 (basic visit);Changes in d-ROMs & BAP, selenium of visits 4 and 5 compared to visit 2 (basic visit);Changes in cortisol at visits 4 and 5 compared to visit 2 (basic visit)