A Multicenter Observational Study on Safety of the Herbal... | NCT04269486

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

NCT04269486

Sponsor

Korea Institute of Oriental Medicine

Status

Terminated

Last Update Posted

Sep 3, 2025Actual

Enrollment

287Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The funding stopped while participants recruited slowly

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Mar 30, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Nov 26, 2019

First Submission Date that Met QC Criteria

Feb 12, 2020

First Posted Date

Feb 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2025

Last Update Posted Date

Sep 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dal-Seok Oh, OMD, PhD, Principal Investigator, Korea Institute of Oriental MedicinePrincipal Investigator

Lead Sponsor

Korea Institute of Oriental MedicineOTHER_GOV

Collaborators

Name	Class
Semyung University	OTHER
Dongshin Seoul Korean Medicine Hospital	UNKNOWN
CHUNG YEON Korean Medicine Hospital	UNKNOWN
Korean Medicine Hospital of Pusan National University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Total 500 inpatients will be observed to assess safety of herbal medicines with the balance of 60 to 110 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

287Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inpatient participant		Inpatients who signed the informed consent form that she will be observed during the hospitalization period

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)	Routine check-up test items and newly developed biomarkers on liver functions	Time-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female whose age is between 19 and 80

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dal-Seok Oh, OMD, PhD	Korea Institute of Oriental Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Five tertiary Korean Medicine Hospital (Jecheon, Yangsan, Gwangju, Seoul, Bundang)		Seoul			South Korea

Label	URL
Online source on the previous study paper	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056486	Chemical and Drug Induced Liver Injury

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders

Browse Leaves

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Browse Branches

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