Liver Enzyme Abnormalities and Risk Factors in Taking Herbal Medicine

November 5, 2018 updated by: Jaseng Hospital of Korean Medicine

Liver Enzyme Abnormalities and Its Risk Factors in Taking Traditional Herbal Medicine in Korea

Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. We assessed the prevalence of liver injury of 6,894 musculoskeletal disease inpatients taking herbal medicine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. The objective of this study is to report on the incidence of liver injury from herbal medicine in musculoskeletal disease patients as large-scale studies are scarce.

Of 32,675 inpatients taking herbal medicine at 7 locations of a Korean medicine hospital between 2005 and 2013, we screened for liver injury in 6,894 patients with liver function tests (LFTs) at admission and discharge. LFTs included t-bilirubin, AST, ALT, and ALP. We assessed for risk factors for liver injury at discharge.

Participants received the most frequently used complementary and alternative medicine treatment contents (herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation) administered to musculoskeletal disease patients at this hospital.

Study Type

Observational

Enrollment (Actual)

6894

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
        • Jaseng Hospital of Korean Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.

Description

Inclusion Criteria:

  • Patients admitted for at least one day who took herbal medicine and at least 2 LFTs during admittance.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alanine aminotransferase (ALT)
Time Frame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Aspartate aminotransferase (AST)
Time Frame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Alkaline phosphatase (ALP)
Time Frame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Total bilirubin (TB)
Time Frame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Change from baseline (admission) in liver function test up to discharge (average 4 wks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaseng Hospital of Korean Medicine

Investigators

  • Principal Investigator: Jinho Lee, Masters, Jaseng Hospital of Korean Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2005

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-CT-2013-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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