An observational study in Drug-Induced Liver Injury, sponsored by Beijing 302 Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-27.
Sponsored by Beijing 302 Hospital · Observational
This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Granule (XLGB Granule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Granule.
The primary objectives of this study include:
(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to XLGB Granule.
75 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 20 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 504 across 38 observational studies indexed under Chemical and Drug Induced Liver Injury.
Browse Chemical and Drug Induced Liver Injury studies →Beijing 302 Hospital is the lead sponsor of 86 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
community sample and primary care clinic.
Abnormalities of serum liver biochemistry achieving one of the criteria as follows:
(i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;
Exclusion Criteria:
The overall individuals taking XLGB Granule with recommended dosage and achieving the inclusion criteria.
The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.
The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.
Time frame: participants will be followed duration intake of XLGB Granule, an expected average within 8 weeks
Clinical features of early liver injuries caused by XLGB Granule assessed by serum parameters of liver function.
Clinical features of early liver injuries caused by XLGB Granule assessed by serum parameters of liver function.
Time frame: participants will be followed duration intake of XLGB Granule, an expected average of 8 weeks
Disease progression of early liver injuries caused by XLGB Granule, i.e. death, liver failure, chronic DILI, recovery.
Disease progression of early liver injuries caused by XLGB Granule, i.e. death, liver failure, chronic DILI, recovery.
Time frame: 8 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chemical and Drug Induced Liver Injury→
Beijing 302 Hospital