Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule

Beijing 302 Hospital

Status: Unknown

Conditions: Drug-Induced Liver Injury

Study type: Observational

Funder types: Other

Identifiers

NCT03091608

302-xxh-XLGBG

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Individuals in accordance with indications for XLGB Granule, including osteoporosis, fracture, osteoarthritis, aseptic necrosis of bone and climacteric;

2. The age range of 18 to 70 years;

3. Individuals taking XLGB Granule 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 Granule;
2. Unconformity to the XLGB Granule drug label;
3. Individual taking XLGB Granule less than 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with XLGB Granule, 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）.

Trial design

1,000 participants in 1 patient group

The individuals taking XLGB Granule

Description:

The overall individuals taking XLGB Granule with recommended dosage and achieving the inclusion criteria.