The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.

Nanjing Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Liver Cirrhosis

Treatments: Drug: Placebo; Drug: Tauroursodeoxycholic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04727320

Ling Lv

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of liver cirrhosis and liver fibrosis in patients requiring medical treatment.

Exclusion criteria

• Patients with end-stage cirrhosis, liver failure, etc. who need liver transplantation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

patient+TUDCA

Experimental group

Treatment:

Drug: Tauroursodeoxycholic acid

patient+placebo

Placebo Comparator group

Treatment:

Drug: Placebo