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

Drug Induced Liver Injury Clinical Trial

Official title:

Safety Assessment of the Frequently Used Herbal Medicines at Inpatient Setting: a Multicenter, Prospective Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04269486
• Other study ID #: KIOS1901
• Status: Active, not recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 287
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Drug Induced Liver Injury
• Drug-Induced Kidney Injury
• Herbal Medicine Adverse Reaction
• Wounds and Injuries

Locations

Country	Name	City	State
Korea, Republic of	Five tertiary Korean Medicine Hospital (Jecheon, Yangsan, Gwangju, Seoul, Bundang)	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Korea Institute of Oriental Medicine	CHUNG YEON Korean Medicine Hospital, DongGuk University, Dongshin Seoul Korean Medicine Hospital, Korean Medicine Hospital of Pusan National University, Semyung University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Activity change from Admission (0 week; ALT) up to discharge (12 weeks; ALT)
Primary	Blood urea nitrogen (BUN) (mg/dL)	Routine check-up test item on kidney functions	Activity change from Admission (0 week; BUN) up to discharge (12 weeks; BUN)
Secondary	Liver function tests: AST (U/L), ALP (U/L), ?-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-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)
Secondary	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-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)

External Links

•   Online source on the previous study paper