None listed
Conditions
Interventions
Drug : After subjects who had experienced physical fatigue lasting for more than one month voluntarily provided written consent for this clinical trial, the principal investigator randomized subjects
Sponsors
Korean Drug
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 or older 2) Individuals who have experienced persistent fatigue (CIS score of 76 or higher) for at least one month as of the screening date 3) Individuals whose Hospital Anxiety and Depression Scale (HADS) assessment results show Anxiety and Depression scores of 10 or lower each as of the screening date 4) Individuals who have heard the explanation of this clinical trial and have voluntarily consented to participate
Exclusion criteria
Exclusion criteria: 1) Individuals with hypersensitivity to any component of the investigational medicinal product 2) Individuals with a confirmed history of surgery, medical history, or concomitant diseases among the following: (1) Individuals diagnosed with hepatitis or cirrhosis, or confirmed to have impaired liver function (2) Individuals diagnosed with alcoholism or drug abuse, or psychiatric and neurological diseases (e.g., depression, sleep disorders, anxiety neurosis, schizophrenia, eating disorders, myasthenia gravis, multiple sclerosis, etc.) (3) Individuals suffering from autoimmune diseases (e.g., multiple sclerosis, lupus, rheumatoid arthritis, etc.) (4) Individuals diagnosed with malignant tumors, tuberculosis, asthma, chronic lung disease, glaucoma, hypothyroidism, anemia, cardiovascular disease, or infectious disease (5) Individuals diagnosed with functional or inflammatory gastrointestinal diseases (e.g., irritable bowel syndrome, functional dyspepsia/constipation/diarrhea, Crohn's disease, ulcerative colitis, etc.) who are currently taking related medication or are expected to need to take it during the clinical trial (6) Persons who have undergone surgery within 2 weeks of the screening date 3) Persons with confirmed results of the following tests at the screening date (1) Uncontrolled hypertension (SBP = 170 mmHg, DBP = 100 mmHg) (2) Uncontrolled diabetes (HbA1c = 8.0%) (3) Body mass index (BMI) = 30 kg/? (4) AST, ALT, ALP, or Total bilirubin is 2 times or more the upper limit of normal at the testing facility (5) Creatinine is 2 times or more the upper limit of normal at the testing facility (6) HIV positive (can be substituted if test results are available from within 12 weeks of the screening date) 4) Persons who are taking, using, needing to take, or are expected to take the following fatigue-inducing drugs during the clinical trial period: Beta-blockers, steroids, immunomodulators, antidepressants, anxiolytics, sleeping pills, antihistamines, etc. 5) Those who have received medical or traditional Korean medicine treatment for chronic fatigue, or who have taken medicines or health functional foods that help improve fatigue within 2 weeks of the screening time 6) Those capable of recovering from fatigue in the event of changes in living environment, such as continuous night work or shift work 7) Pregnant or breastfeeding women, or women planning to become pregnant during the clinical trial period, or those who do not consent to the use of medically acceptable contraceptive methods*, and their spouses (or partners) *Medically acceptable contraceptive methods: Copper intrauterine devices (copper loops), condoms, tubal ligation, spermicides, vaginal insertable contraceptives, subcutaneous implants, female condoms, etc. 8) Those who have participated in another clinical trial and received or been administered investigational drugs or medical devices within 12 weeks of the screening time 9) Any person confirmed by the Principal Investigator (or authorized investigator) to have medical findings that make it difficult or unsuitable to perform this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose Checklist Individual Strength(CIS) score improved to less than 76 at 4 weeks after administration of the investigational drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose Checklist Individual Strength(CIS) score improved to less than 76 at 2 weeks after administration of the investigational drug;Change in Checklist Individual Strength(CIS) score from baseline at weeks 2 and 4;Change in Fatigue severity scale(FSS) score at weeks 2 and 4 relative to baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Wook Song
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed