Drug-Induced Liver InjuryNCT02299739
Liver Enzyme Abnormalities and Risk Factors in Taking Herbal Medicine
An observational study of Drug-Induced Liver Injury and Musculoskeletal Diseases, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
Trial summary
Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-Induced Liver Injury, Musculoskeletal Diseases
- What is being tested?
- Herbal medicine, Acupuncture and Pharmacopuncture
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 6,894 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2005to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.
Who may be able to join
- Patients admitted for at least one day who took herbal medicine and at least 2 LFTs during admittance.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: Liver Enzyme Abnormalities and Its Risk Factors in Taking Traditional Herbal Medicine in Korea
Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. We assessed the prevalence of liver injury of 6,894 musculoskeletal disease inpatients taking herbal medicine.
Read the detailed description
Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. The objective of this study is to report on the incidence of liver injury from herbal medicine in musculoskeletal disease patients as large-scale studies are scarce.
Of 32,675 inpatients taking herbal medicine at 7 locations of a Korean medicine hospital between 2005 and 2013, we screened for liver injury in 6,894 patients with liver function tests (LFTs) at admission and discharge. LFTs included t-bilirubin, AST, ALT, and ALP. We assessed for risk factors for liver injury at discharge.
Participants received the most frequently used complementary and alternative medicine treatment contents (herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation) administered to musculoskeletal disease patients at this hospital.
- Being tested
- Herbal medicine, Acupuncture, Pharmacopuncture, Bee venom pharmacopuncture, Chuna manipulation
- Keywords
- Herbal Medicine, Complementary Therapies, Liver Function Tests, Risk Factors
- Medical subject headings
- Chemical and Drug Induced Liver Injury, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal medicineDrug
Also called Traditional herbal medicine
Herbal medicine was taken 3 times daily in dried powder (2g) and water-base decoction form (120ml) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica).
AcupunctureProcedure or surgery
Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.
PharmacopunctureProcedure or surgery
Select ingredients similar to those included in the oral herbal medicine (Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica) were freeze dried into powder form after decoction, then diluted in normal saline and adjusted for acidity and pH to be used in injections. The pharmacopuncture injections were injected once daily to the amount of 1 cc and Ah-shi points and local acupuncture points (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
Bee venom pharmacopunctureProcedure or surgery
Bee venom pharmacopuncture was applied after confirming a negative reaction to the hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) was injected at 4-5 acupoints at the physician's discretion. Each acupuncture point was injected with approximately 0.2 cc to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
Chuna manipulationProcedure or surgery
Chuna was administered 3-5 times a week. Chuna is a Korean version of spinal manipulation that incorporates conventional spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine aminotransferase (ALT)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Measured: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Aspartate aminotransferase (AST)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Measured: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Alkaline phosphatase (ALP)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Measured: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Total bilirubin (TB)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Measured: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startDec 2005
- Primary completionDec 2013
- Study completionDec 2013
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,894 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Hospital of Korean Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinho Lee, Masters, Principal investigator, Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299739
- Sponsor's protocol ID
- JS-CT-2013-02
- Status last verified
- Nov 2018
- First submitted
- 18 Nov 2014
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Enzyme Abnormalities and Its Risk Factors in Taking Traditional Herbal Medicine in Korea
- ClinicalTrials.gov ID
- NCT02299739
- Acronym / sponsor ID
- JS-CT-2013-02
- Keywords
- Herbal Medicine, Complementary Therapies, Liver Function Tests, Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,894 participants (actual)
- Lead sponsor
- Jaseng Hospital of Korean MedicineUniversity, hospital or other
- Study start
- Dec 2005 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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.
Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. We assessed the prevalence of liver injury of 6,894 musculoskeletal disease inpatients taking herbal medicine.
Detailed description
Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. The objective of this study is to report on the incidence of liver injury from herbal medicine in musculoskeletal disease patients as large-scale studies are scarce.
Of 32,675 inpatients taking herbal medicine at 7 locations of a Korean medicine hospital between 2005 and 2013, we screened for liver injury in 6,894 patients with liver function tests (LFTs) at admission and discharge. LFTs included t-bilirubin, AST, ALT, and ALP. We assessed for risk factors for liver injury at discharge.
Participants received the most frequently used complementary and alternative medicine treatment contents (herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation) administered to musculoskeletal disease patients at this hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.
Key inclusion criteria (1 listed)
- Patients admitted for at least one day who took herbal medicine and at least 2 LFTs during admittance.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal medicineAlso: Traditional herbal medicineHerbal medicine was taken 3 times daily in dried powder (2g) and water-base decoction form (120ml) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica). | Drug | – |
| AcupunctureAcupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points. | Procedure or surgery | – |
| PharmacopunctureSelect ingredients similar to those included in the oral herbal medicine (Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica) were freeze dried into powder form after decoction, then diluted in normal saline and adjusted for acidity and pH to be used in injections. The pharmacopuncture injections were injected once daily to the amount of 1 cc and Ah-shi points and local acupuncture points (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea). | Procedure or surgery | – |
| Bee venom pharmacopunctureBee venom pharmacopuncture was applied after confirming a negative reaction to the hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) was injected at 4-5 acupoints at the physician's discretion. Each acupuncture point was injected with approximately 0.2 cc to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea). | Procedure or surgery | – |
| Chuna manipulationChuna was administered 3-5 times a week. Chuna is a Korean version of spinal manipulation that incorporates conventional spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. | Procedure or surgery | – |
Primary outcome
Alanine aminotransferase (ALT)
Time frame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Aspartate aminotransferase (AST)
Time frame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Alkaline phosphatase (ALP)
Time frame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Total bilirubin (TB)
Time frame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Participants were followed for the duration of hospital stay, an average of 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
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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.
Jinho Lee, Masters principal investigator
Jaseng Hospital of Korean 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 Musculoskeletal Diseases, run by Jaseng Hospital of Korean 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Nov 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) (time frame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)). The study lists 4 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 7 Nov 2018.