Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Registry Study to Surveil Early Liver Injuries Caused by Xianlin Gubao Granule (XLGB Granule)

Conditions
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Drug-Induced Liver Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals in accordance with indications for XLGB Granule, including osteoporosis, fracture, osteoarthritis, aseptic necrosis of bone and climacteric; The age range of 18 to 70 years; Individuals taking XLGB Granule over 2 weeks; 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; Individuals can provide informed consent form. Exclusion Criteria: Individuals without indications for XLGB Granule; Unconformity to the XLGB Granule drug label; Individual taking XLGB Granule less than 2 weeks; Individuals taking other hepatotoxic drugs combined with XLGB Granule, simultaneously; Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The individuals taking XLGB Granule<br>The overall individuals taking XLGB Granule with recommended dosage and achieving the inclusion criteria. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | participants will be followed duration intake of XLGB Granule, an expected average within 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | participants will be followed duration intake of XLGB Granule, an expected average of 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Induced Liver Injury