Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04269486 |
Other study ID # |
KIOS1901 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2019 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
March 2023 |
Source |
Korea Institute of Oriental Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.