TerminatedNot Applicable

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

Stopped: The funding stopped while participants recruited slowly

South Korea287 participantsStarted 2019-07-01

Plain-language 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.

Who can participate

Age range19 Years – 80 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

Blood urea nitrogen (BUN) (mg/dL)

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

Trial details

NCT IDNCT04269486

SponsorKorea Institute of Oriental Medicine

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-03-30

View on ClinicalTrials.gov More Drug Induced Liver Injury trials