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

NCT04269486 | Terminated DMC

• 1 other identifier: KIOS1901
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Safety; Herbal Medicine; Drug Induced Liver Injury; Drug-Induced Kidney Injury; Prospective Observation; Multicenter Study

Outcome Measures

Primary Outcomes (2)

• Alanine aminotransferase (ALT) (U/L), if ALT >3 upper normal limit, Roussel uclaf casuality assessment method scoring

  Routine check-up test item and causality assessment on liver functions

  Activity change from Admission (0 week; ALT) up to discharge (12 weeks; ALT)

• Blood urea nitrogen (BUN) (mg/dL)

  Routine check-up test item on kidney functions

  Activity change from Admission (0 week; BUN) up to discharge (12 weeks; BUN)

Secondary Outcomes (2)

• 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-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)

• 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-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)

Study Arms (1)

Inpatient participant

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

Eligibility Criteria

• Age: 19 Years - 80 Years
• Gender Eligibility Details: Female whose age is between 19 and 80
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The female inpatients who showed their autonomy and voluntarily signed informed consent on the observations thorughout hospitalization period.

You may qualify if:

• 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.

You may not qualify if:

• Who were short of stay for 2 weeks or stopped intaking herbal medicine
• Who had problems physically or mentally by investigator

Sponsors & Collaborators

• Korea Institute of Oriental Medicine: lead
• Semyung University: collaborator
• Dongshin Seoul Korean Medicine Hospital: collaborator
• CHUNG YEON Korean Medicine Hospital: collaborator
• Korean Medicine Hospital of Pusan National University: collaborator
• DongGuk University: collaborator

Study Sites (1)

Five tertiary Korean Medicine Hospital (Jecheon, Yangsan, Gwangju, Seoul, Bundang)

Seoul, South Korea

Location

Related Links

• Online source on the previous study paper

Biospecimen

Retention: SAMPLES WITH DNA

Liver for AST, ALT, ALP, γ-GT, total Bilirubin and mircoRNA-122, GLDH Kidney for sCr, uCr, BUN and NGAL, KIM-1

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Officials

• Dal-Seok Oh, OMD, PhD

  Korea Institute of Oriental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: February 13, 2020
• Study Start: July 1, 2019
• Primary Completion: March 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)