Drug Induced Liver InjuryNCT04269486
A Multicenter Observational Study on Safety of the Herbal Medicines at Inpatient Setting
An observational study of Drug Induced Liver Injury and Drug-Induced Kidney Injury, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Drug Induced Liver Injury, Drug-Induced Kidney Injury, Herbal Medicine Adverse Reaction
- How many people
- 287 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The female inpatients who showed their autonomy and voluntarily signed informed consent on the observations thorughout hospitalization period.
Who may be able to join
- 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.
Who cannot join
- Who were short of stay for 2 weeks or stopped intaking herbal medicine
- Who had problems physically or mentally by investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Five tertiary Korean Medicine Hospital (Jecheon, Yangsan, Gwangju, Seoul, Bundang)
Seoul
About this study
Official title: Safety Assessment of the Frequently Used Herbal Medicines at Inpatient Setting: a Multicenter, Prospective Observational Study
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.
Read the 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.
- Keywords
- Safety, Herbal Medicine, Drug Induced Liver Injury, Drug-Induced Kidney Injury, Prospective Observation, Multicenter Study
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient participant | Inpatients who signed the informed consent form that she will be observed during the hospitalization period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Routine check-up test items and newly developed biomarkers on liver functions
Measured: 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
Routine check-up test items and newly developed biomarkers on kidney functions
Measured: Time-dependent Profiles from Admission (0 week), 1 week, 2 weeks, 3 weeks up to discharge (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Jul 2019
- Primary completion30 Mar 2024
- Study completion31 Dec 2024
Why it stopped: The funding stopped while participants recruited slowly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Induced Liver InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Institute of Oriental Medicine
- Sponsor type
- Other government
- Collaborators
- Semyung University, Dongshin Seoul Korean Medicine Hospital, CHUNG YEON Korean Medicine Hospital, Korean Medicine Hospital of Pusan National University, DongGuk University
- Responsible party
- Principal investigator, Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine
- Investigators
- Dal-Seok Oh, OMD, PhD, Principal investigator, Korea Institute of Oriental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269486
- Sponsor's protocol ID
- KIOS1901
- Status last verified
- Aug 2025
- First submitted
- 26 Nov 2019
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of the Frequently Used Herbal Medicines at Inpatient Setting: a Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04269486
- Acronym / sponsor ID
- KIOS1901
- Keywords
- Safety, Herbal Medicine, Drug Induced Liver Injury, Drug-Induced Kidney Injury, Prospective Observation, Multicenter Study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The funding stopped while participants recruited slowly
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Korea Institute of Oriental MedicineOther government
- Collaborators
- Semyung University, Dongshin Seoul Korean Medicine Hospital, CHUNG YEON Korean Medicine Hospital, Korean Medicine Hospital of Pusan National University, DongGuk University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient participant | – | –Inpatients who signed the informed consent form that she will be observed during the hospitalization period |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The female inpatients who showed their autonomy and voluntarily signed informed consent on the observations thorughout hospitalization period.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Who were short of stay for 2 weeks or stopped intaking herbal medicine
- Who had problems physically or mentally by investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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)
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)
Results and safety
The study was stopped early (reason given: The funding stopped while participants recruited slowly). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Online source on the previous study paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dal-Seok Oh, OMD, PhD principal investigator
Korea Institute of Oriental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Induced Liver Injury and Drug-Induced Kidney Injury, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The funding stopped while participants recruited slowly). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.