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 range

19 Years – 80 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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