A Multicenter Observational Study on Safety of the Herbal Medicines at Inpatient Setting

NCT04269486 — Terminated, 287 participants, Korea Institute of Oriental Medicine
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Safety Assessment of the Frequently Used Herbal Medicines at Inpatient Setting: a Multicenter, Prospective Observational Study

RegistryNCT04269486
StatusTerminated - The funding stopped while participants recruited slowly
Study typeObservational
Enrollment287 (Actual)
SponsorKorea Institute of Oriental Medicine (Other gov); collaborators: Semyung University, Dongshin Seoul Korean Medicine Hospital, CHUNG YEON Korean Medicine Hospital, Korean Medicine Hospital of Pusan National University, DongGuk University
ConditionsDrug Induced Liver Injury, Drug-Induced Kidney Injury, Herbal Medicine Adverse Reaction
Datesstart 2019-07-01, primary completion 2024-03-30, completion 2024-12-31, first posted 2020-02-13, last updated 2025-09-03
Locations1 site in South Korea

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Inpatient participantInpatients who signed the informed consent form that she will be observed during the hospitalization period

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: Female, ages: 19 Years to 80 Years

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

+Locations (1)

FacilityCityCountryStatus
Five tertiary Korean Medicine Hospital (Jecheon, Yangsan, Gwangju, Seoul, Bundang)SeoulSouth Korea

+Investigators