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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

Detailed Description

Total 500 inpatients will be observed to assess safety of herbal medicines with the balance of 70 to 130 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.

Arms, Groups and Cohorts

  • Inpatient participant
    • Inpatients who signed the informed consent form that she will be observed during the hospitalization period

Clinical Trial Outcome Measures

Primary Measures

  • Alanine aminotransferase (ALT) (U/L), if ALT >3 upper normal limit, Roussel uclaf casuality assessment method scoring
    • Time Frame: Activity change from Admission (0 week; ALT) up to discharge (12 weeks; ALT)
    • Routine check-up test item and causality assessment on liver functions
  • Blood urea nitrogen (BUN) (mg/dL)
    • Time Frame: Activity change from Admission (0 week; BUN) up to discharge (12 weeks; BUN)
    • Routine check-up test item on kidney functions

Secondary Measures

  • Liver function tests: AST (U/L), ALP (U/L), γ-GT (U/L), total bilirubin (mg/dL). Drug induced-liver injury biomarkers: microRNA-122 (miR122), Glutamate dehydrogenase (GLDH)
    • Time Frame: Time-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)
    • Routine check-up test items and newly developed biomarkers on liver functions
  • Kidney function tests: Urine creatinine (mg/dL), Serum creatinine (mg/dL). Drug induced-kidney injury biomarkers: Neutrophil gelatinase-associated lipocalin, Kidney Injury Molecule-1
    • Time Frame: Time-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)
    • Routine check-up test items and newly developed biomarkers on kidney functions

Participating in This Clinical Trial

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
  • Gender Eligibility: Female

    Female whose age is between 19 and 80

    Minimum Age: 19 Years

    Maximum Age: 80 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Korea Institute of Oriental Medicine
    • Collaborator
      • Semyung University
    • Provider of Information About this Clinical Study
      • Principal Investigator: Dal-Seok Oh, OMD, PhD, Principal Investigator – Korea Institute of Oriental Medicine
    • Overall Official(s)
      • Dal-Seok Oh, OMD, PhD, Principal Investigator, Korea Institute of Oriental Medicine
    • Overall Contact(s)
      • Jihye Jang, MS, +82-42-869-2706, jihye1684@kiom.re.kr

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