None listed
Conditions
Interventions
Drug : Subjects are randomly assigned to either test Gongjindan group or Ssanghwa-tang group or Placebo group and distributed with clinical trial drugs and dosing diaries. The investigator instructs
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FSS score at Visit 4 compared to Visit 2 (basic visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Korea, Republic of
Contacts
Public ContactKibong Kim
Pusan National University Korean Medicine Hospital
Outcome results
None listed