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

NCT04269486 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 287

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Drug Induced Liver Injury
  • Drug-Induced Kidney Injury
  • Herbal Medicine Adverse Reaction

Sponsors & Collaborators

  • Semyung University

    collaborator OTHER
  • Dongshin Seoul Korean Medicine Hospital

    collaborator UNKNOWN
  • CHUNG YEON Korean Medicine Hospital

    collaborator UNKNOWN
  • Korean Medicine Hospital of Pusan National University

    collaborator OTHER
  • DongGuk University

    collaborator OTHER
  • Korea Institute of Oriental Medicine

    lead OTHER_GOV

Principal Investigators

  • Dal-Seok Oh, OMD, PhD · Korea Institute of Oriental Medicine

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2024-03-30
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04269486 on ClinicalTrials.gov