Drug-Induced Kidney Injury, Drug Induced Liver Injury, Herbal Medicine Adverse Reaction
Conditions
Keywords
Safety, Herbal Medicine, Drug Induced Liver Injury, Drug-Induced Kidney Injury, Prospective Observation, Multicenter Study
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Semyung University
Dongshin Seoul Korean Medicine Hospital
CHUNG YEON Korean Medicine Hospital
Korean Medicine Hospital of Pusan National University
DongGuk University
Korea Institute of Oriental Medicine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female whose age is between 19 and 80 * Inpatient expected to stay at least 2 weeks and to intake herbal medicine * Who signed voluntarily informed consent.
Exclusion criteria
* Who were short of stay for 2 weeks or stopped intaking herbal medicine * Who had problems physically or mentally by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alanine aminotransferase (ALT) (U/L), if ALT >3 upper normal limit, Roussel uclaf casuality assessment method scoring | Activity change from Admission (0 week; ALT) up to discharge (12 weeks; ALT) | Routine check-up test item and causality assessment on liver functions |
| Blood urea nitrogen (BUN) (mg/dL) | Activity change from Admission (0 week; BUN) up to discharge (12 weeks; BUN) | Routine check-up test item on kidney functions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Time-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks) | Routine check-up test items and newly developed biomarkers on liver functions |
| Kidney function tests: Urine creatinine (mg/dL), Serum creatinine (mg/dL). Drug induced-kidney injury biomarkers: Neutrophil gelatinase-associated lipocalin, Kidney Injury Molecule-1 | Time-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks) | Routine check-up test items and newly developed biomarkers on kidney functions |
Countries
South Korea
Outcome results
None listed