A Prospective, Multicenter Observational Study to Access Safety of Herbal Medicines

Not Applicable

Completed

Conditions: Not Applicable

Registration Number: KCT0001279

Lead Sponsor: Daejeon Korean Medicine Hospital of Daejeon University

Brief Summary: Discrepant incidence has been reported regarding the incidence of herb-induced liver injury (HILI). To address the growing worldwide concern of HILI, we evaluated the risk of HILI in a nationwide prospective study. Between April 2013 and January 2016, 1001 inpatients (360 males and 641 females) from 10 tertiary hospitals throughout South Korea were treated with herbal drugs and had their liver enzymes periodically measured. A total of six patients met the criteria for HILI with RUCAM scores ranging from 4 to 7. All these participants were women and developed the hepatocellular type of HILI. One HILI participant met the criteria for Hy's law; however, none of six cases presented clinical symptoms related to liver injury. This is the first nationwide prospective study that estimated the extent of the incidence of HILI [total: 0.60%, 95% confidence interval (CI) 0.12-1.08; women: 0.95%, 95% CI 0.19-1.68] and described its features in hospitalized participants.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1000

Inclusion Criteria

1) Patients over the age of 18
2) Patients who will be administered herbal medicine over two weeks
3) Patietns whose blood test(liver function and renal function test) is normal at baseline
4) Patients who has no psychological health issues
5) Patients who consent to involve this randomized clinical trial by themselves

Exclusion Criteria

1) Patients who suffer chronic liver diseases(viral hepatitis, liver cirrhosis, liver cancer)
2) Patients who suffer chronic renal diseases(chronic renal failure, renal cell carcinoma)
3) Patients who have suffered toxic hepatitis
4) Patients who have cancers
5) Patients who suffer cardio-vascular, endocrine, blood and psychological diseases
6) Patients who have been taking western medicines over one months except blood pressure, diabetes mellitus, hyperlipidemia and anti-coagulation medicines
7) Patients who have been organ-transplanted or are taking immunosuppresants
8) Pregnant
9) Patients who have serious psychological diseases