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

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    500
  • sponsor
    Korea Institute of Oriental Medicine
Updated on 21 April 2022

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.

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.

Details
Condition Drug Induced Liver Injury, Drug-Induced Kidney Injury, Herbal Medicine Adverse Reaction
Clinical Study IdentifierNCT04269486
SponsorKorea Institute of Oriental Medicine
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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
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