The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 主要终点
- Liver biopsy
研究概览
简要总结
This study is a prospective study. We signed an informed consent form with patients with liver fibrosis and took tauroursodeoxycholic acid orally for half a year. After half a year, liver biopsy was performed using histopathology, immunohistochemistry, and polymerase chain reaction, Western blotting method was used to determine the expression level of fibrosis-related markers to verify the effect of taurodeoxycholic acid on patients with liver fibrosis.
详细描述
Tauroursodeoxycholic acid is an effective component of bear bile, which has obvious curative effects in the treatment of gallstones and liver diseases. In recent years, the research field of tauroursodeoxycholic acid has been very active, and its chemical synthesis has also attracted much attention. The usage is swallowing with water before going to bed at night. It must be taken regularly, one capsule at a time (250mg), once a day. After 6 months of continuous use, liver biopsy was performed after 6 months. Telling the patient to swallow with water before going to bed at night. It must be taken regularly, one capsule at a time (250mg), once a day. After 6 months of continuous use, liver B-ultrasound biopsy was performed to observe the effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of liver cirrhosis and liver fibrosis in patients requiring medical treatment.
排除标准
- •Patients with end-stage cirrhosis, liver failure, etc. who need liver transplantation.
研究组 & 干预措施
patient+TUDCA
干预措施: Tauroursodeoxycholic acid (Drug)
patient+placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Liver biopsy
时间窗: up to 24 weeks
Synthesis of liver extracellular matrix（Synthesis, degradation）
次要结局
- Liver ultrasound(up to 24 weeks)