Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill.

Study Overview
=================
Brief Summary
-----------------
This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Pill (XLGB Pill) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Pill.

Detailed Description
-----------------
The primary objectives of this study include: (i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Pill; (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 Pill.

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

Conditions
-----------------
Drug-Induced Liver Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals in accordance with indications for XLGB Pill, including symptoms of osteoporosis; The age range of 18 to 70 years； Individuals taking XLGB Pill 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 Pill; Unconformity to the XLGB Pill drug label; Individual taking XLGB Pill less than 2 weeks; Individuals taking other hepatotoxic drugs combined with XLGB Pill, 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
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
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 Pill. | The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Pill. | participants will be followed duration intake of XLGB Pill, an expected average within 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical features of early liver injuries caused by XLGB Pill assessed by serum parameters of liver function. | Clinical features of early liver injuries caused by XLGB Pill assessed by serum parameters of liver function. | participants will be followed duration intake of XLGB Pill, an expected average of 8 weeks | 

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