- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299739
Liver Enzyme Abnormalities and Risk Factors in Taking Herbal Medicine
Liver Enzyme Abnormalities and Its Risk Factors in Taking Traditional Herbal Medicine in Korea
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gangnam-Gu
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Seoul, Gangnam-Gu, Korea, Republic of, 135-896
- Jaseng Hospital of Korean Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Jinho Lee, Masters, Jaseng Hospital of Korean Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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