A Registry Study to Surveil Early Liver Injuries Caused by Xianlin Gubao Granule (XLGB Granule)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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）.
结局指标
主要结局
The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.
时间窗: participants will be followed duration intake of XLGB Granule, an expected average within 8 weeks
The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.
次要结局
- 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)
研究者
Xiaohe Xiao
Director
Beijing 302 Hospital