None listed
Conditions
Interventions
Drug : For CV1 (Jeil Kyungokgo) group, take 1 pack (22.5 g) twice a day for adults before or between meals (between meals). For P (placebo) group, take 1 packet (22.5 g) twice a day before or between
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Adults aged 19 to 65 who have been diagnosed with COVID-19 at least 12 weeks prior -Individuals who have experienced persistent fatigue for more than four weeks, which was not present before their COVID-19 diagnosis -Individuals with an FSS (Fatigue Severity Scale) score of 4 or higher -Individuals whose fatigue cannot be explained by other medical conditions -Individuals with no significant cognitive impairment who voluntarily agree to participate in the study through written informed consent
Exclusion criteria
Exclusion criteria: -Individuals with psychological or emotional factors that may contribute to fatigue -Individuals experiencing symptoms such as loss of appetite, nausea, or vomiting -Patients suspected of having sequelae from severe COVID-19, including shortness of breath, chest pain, or cough -Individuals with a history or current diagnosis of underlying conditions that may cause fatigue (e.g., cancer, sleep disorders, active hepatitis A, chronic hepatitis, liver cirrhosis, chronic renal failure, active tuberculosis, latent tuberculosis, asthma, multiple sclerosis, etc.) -Individuals with conditions that may affect drug absorption (e.g., dysphagia, clinically significant digestive disorders, genetic disorders such as galactose intolerance, -Lapp lactase deficiency, or glucose-galactose malabsorption) -Individuals with uncontrolled diabetes (HbA1c = 6.5) -Individuals with uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 100 mmHg) -Individuals with a history of allergy to the investigational drug (Kyungok-go) -Individuals with liver or kidney disease, or blood test results showing AST, ALT, BUN, or creatinine levels exceeding twice the upper normal limit -Pregnant, potentially pregnant, or breastfeeding women -Individuals who do not agree to use contraception during the study period -Individuals who have participated in another clinical study within 30 days prior to enrollment -Individuals who have taken herbal medicine, botanical products, over-the-counter drugs, dietary supplements, vitamins, or health functional foods that may affect fatigue within one month before study participation -Individuals who have taken medications affecting fatigue, including corticosteroids (within one month prior to participation), immunosuppressants (within three months), psychotropic drugs (within one month), or hormone therapy (within one month) -Individuals who have undergone organ or bone marrow transplantation, or have undergone fatigue-related treatments (e.g., surgery) within three months prior to participation -High-risk alcohol consumers (drinking alcohol at least twice a week, with an average intake per session of = 7 drinks for men or = 5 drinks for women, where one drink is defined as 4 cans of beer, 4 bowls of makgeolli, 4 glasses of wine, 1 bottle of soju, or 4 shots of whiskey for men; and 3 cans of beer, 3 bowls of makgeolli, 3 glasses of wine, ¾ bottle of soju, or 3 shots of whiskey for women) -Long-term heavy smokers (smoking at least one pack per day for more than 10 years) -Individuals deemed unsuitable for study participation due to clinically significant psychiatric symptoms, medical conditions, or abnormal laboratory findings as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale (FSS) scores after herbal medicine administration for up to 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Final medication adherence;Differences in final medication adherence by herbal medicine administration group;Fatigue Severity Scale (FSS) score;ChFS(Chalder Fatigue Scale) score and subscale score;EQ-5D-5L score;PSQI-K (Korean version of Pittsburgh Sleep Quality Index) Global score;K-MOCA(Korean-Montreal cognitive assessment) score;BDI (Becks’ depression inventory) score;DF(digit forward) score, DB(digit backward) score, DF-DB score;Analysis of target recruitment rate, dropout rate, and dropout reason for feasibility evaluation;Final treatment success rate | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Hun Kim
Kyung Hee University Oriental Medical Center
Outcome results
None listed