Drug-Induced Liver Injury Clinical Trial
Official title:
A Registry Study to Surveil Early Liver Injuries Caused by Xianlin Gubao Capsule (XLGB Capsule)
This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Capsule (XLGB Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Capsule.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Individuals in accordance with indications for XLGB Capsule, including osteoarthritis, and lumbar muscle strain; 2. The age range of 18 to 70 years; 3. Individuals taking XLGB Capsule over 2 weeks; 4. 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; 5. Individuals can provide informed consent form. Exclusion Criteria: 1. Individuals without indications for XLGB Capsule; 2. Unconformity to the XLGB Capsule drug label; 3. Individual taking XLGB Capsule less than 2 weeks; 4. Individuals taking other hepatotoxic drugs combined with XLGB Capsule, simultaneously; 5. Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003). |
Country | Name | City | State |
---|---|---|---|
China | 302 Military Hospital | Beijing Shi | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing 302 Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Disease progression of early liver injuries caused by XLGB Capsule, i.e. death, liver failure, chronic DILI, recovery. | Disease progression of early liver injuries caused by XLGB Capsule, i.e. death, liver failure, chronic DILI, recovery. | 8 weeks | |
Primary | The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Capsule. | The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Capsule. | participants will be followed duration intake of XLGB Capsule, an expected average within 8 weeks | |
Secondary | Clinical features of early liver injuries caused by XLGB Capsule assessed by serum parameters of liver function. | Clinical features of early liver injuries caused by XLGB Capsule assessed by serum parameters of liver function. | participants will be followed duration intake of XLGB Capsule, an expected average of 8 weeks |
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