Kyungokgo for fatigue in post-COVID 19 survivors: prospective multicenter case series

Not Applicable

Conditions: Codes for special purposes

Registration Number: KCT0009410

Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Those aged 19 years or older and at least 12 weeks have passed since being diagnosed with COVID-19
-Those who has continuously experienced fatigue for 4 more than weeks that they did not experience before being diagnosed with COVID-19.
-Those who scored 36 or more Fatigue Severity Scale (FSS) score.
-Participants do not have any problems with overall cognitive function and voluntarily agreed to participate in the study through written consent

Exclusion Criteria

-Those with a past or current history of organic diseases that can cause fatigue (cancer, sleep disorders, chronic hepatitis, cirrhosis, chronic renal failure, tuberculosis, asthma, multiple sclerosis)
-Those with diseases that may affect the taking or absorption of drugs (dysphagia, clinically serious digestive disorders, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption)
-Those with uncontrolled diabetes
-Those with a history of allergy to clinical research drugs (Kyungokgo)
-Those with a history of liver disease or kidney disease, or if AST, ALT, BUN, and Creatinine exceed three times the upper limit of normal on a blood test.
-Women who are pregnant, may become pregnant, or are lactating
-Participating in another study within 30 days prior to participating in a clinical study
-When the researcher determines that participation in the study is difficult due to clinically significant psychiatric symptoms, medical disease, laboratory findings, etc.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale (FSS) scores after herbal medicine administration for up to 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Final medication adherence;Fatigue Severity Scale (FSS) scores ;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;Computerized neurocognitive function test score;Short Physical Performance Battery (SPPB);Analysis of target recruitment rate, dropout rate, and dropout reason for feasibility evaluation;Final treatment success rate