Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269486
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Semyung University
Dongshin Seoul Korean Medicine Hospital
CHUNG YEON Korean Medicine Hospital
Korean Medicine Hospital of Pusan National University
Information provided by (Responsible Party):
Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine

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.

Condition or disease
Drug Induced Liver Injury Drug-Induced Kidney Injury Herbal Medicine Adverse Reaction

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety Assessment of the Frequently Used Herbal Medicines at Inpatient Setting: a Multicenter, Prospective Observational Study
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herbal Medicine

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



Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female whose age is between 19 and 80
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269486


Contacts
Layout table for location contacts
Contact: Jihye Jang, MS +82-42-869-2706 jihye1684@kiom.re.kr
Contact: Aeran Kim, PhD +82-42-868-9315 arkim@kiom.re.kr

Locations
Layout table for location information
Korea, Republic of
Four tertiary Korean Medicine Hospital (Jecheon, Yangsan, Gwangju, Seoul) Recruiting
Seoul, Korea, Republic of
Contact: Eugene Choi, BS    +82-10-2861-8163    onehorn@daum.net   
Sponsors and Collaborators
Korea Institute of Oriental Medicine
Semyung University
Dongshin Seoul Korean Medicine Hospital
CHUNG YEON Korean Medicine Hospital
Korean Medicine Hospital of Pusan National University
Investigators
Layout table for investigator information
Principal Investigator: Dal-Seok Oh, OMD, PhD Korea Institute of Oriental Medicine

Additional Information:
Layout table for additonal information
Responsible Party: Dal-Seok Oh, OMD, PhD, Principal Investigator, Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT04269486    
Other Study ID Numbers: KIOS1901
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine:
Safety
Herbal Medicine
Drug Induced Liver Injury
Drug-Induced Kidney Injury
Prospective Observation
Multicenter Study
Additional relevant MeSH terms:
Layout table for MeSH terms
Chemical and Drug Induced Liver Injury
Wounds and Injuries
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning