An observational study in Drug Induced Liver Injury, Drug-Induced Kidney Injury and Herbal Medicine Adverse Reaction, sponsored by Korea Institute of Oriental Medicine. Terminated at 1 site in South Korea. Open to female participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Korea Institute of Oriental Medicine · Observational
Prospective observations on safety of the herbal medicines regarding liver and kidney injuries at inpatient setting of four sites in South Korea which are located at each quadrant of the country. In a previous study (PMID 28634823), six women presented liver injuries by herbs and similar findings were also reported. That knowledge has been developed to design the observations of females (19-80 ages) at least 2 weeks' hospitalization with weekly routine lab tests to obtain the occurrence of liver or kidney injuries and the profiles on micro biomarkers throughout the hospitalization period, and then, the follow-up test will be conducted in outpatient setting.
Total 500 inpatients will be observed to assess safety of herbal medicines with the balance of 60 to 110 each site. After obtaining the informed consent from patient, blood draw and urine collection are conducted prior to intake of the herbal medicine, blood draw and urine collection are routinely done every week throughout the whole admission period. The primary outcomes are, 1) liver for alanine aminotransferase (ALT), RUCAM (in case of causality assessment when ALT≥3 upper normal limit) and new biomarker, mircoRNA-122 and 2) kidney for urine creatinine, blood urea nitrogen (BUN) and new biomarker, Neutrophil gelatinase-associated lipocalin (NGAL). The secondary outcomes are, 1) liver for aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyltransferase (γ-GT), total bilirubin and new biomarker, glutamate dehydrogenase (GLDH) and 2) kidney for serum creatinine and new biomarker, kidney injury molecule-1 (KIM-1). The follow-up will be done by the study doctors based on their decision on the inpatient after discharge.
75 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 20 are open to participants now.
This study's enrollment of 287 is below the median of 504 across 38 observational studies indexed under Chemical and Drug Induced Liver Injury.
Browse Chemical and Drug Induced Liver Injury studies →Korea Institute of Oriental Medicine is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The female inpatients who showed their autonomy and voluntarily signed informed consent on the observations thorughout hospitalization period.
Exclusion Criteria:
Inpatients who signed the informed consent form that she will be observed during the hospitalization period
Alanine aminotransferase (ALT) (U/L), if ALT >3 upper normal limit, Roussel uclaf casuality assessment method scoring
Routine check-up test item and causality assessment on liver functions
Time frame: Activity change from Admission (0 week; ALT) up to discharge (12 weeks; ALT)
Blood urea nitrogen (BUN) (mg/dL)
Routine check-up test item on kidney functions
Time frame: Activity change from Admission (0 week; BUN) up to discharge (12 weeks; BUN)
Liver function tests: AST (U/L), ALP (U/L), γ-GT (U/L), total bilirubin (mg/dL). Drug induced-liver injury biomarkers: microRNA-122 (miR122), Glutamate dehydrogenase (GLDH)
Routine check-up test items and newly developed biomarkers on liver functions
Time frame: Time-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)
Kidney function tests: Urine creatinine (mg/dL), Serum creatinine (mg/dL). Drug induced-kidney injury biomarkers: Neutrophil gelatinase-associated lipocalin, Kidney Injury Molecule-1
Routine check-up test items and newly developed biomarkers on kidney functions
Time frame: Time-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)
Plan to share: No
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Chemical and Drug Induced Liver Injury→
Korea Institute of Oriental Medicine