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

NCT ID: NCT04727320

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2021-07-30

Brief Summary

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.

Detailed 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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

patient+TUDCA

Group Type: EXPERIMENTAL

Tauroursodeoxycholic acid

Intervention Type: DRUG

Oral TUDCA, once a day, one tablet (250mg) at a time for 6 months

patient+placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo, once a day, one tablet at a time for 6 months

Interventions

Tauroursodeoxycholic acid

Oral TUDCA, once a day, one tablet (250mg) at a time for 6 months

Intervention Type: DRUG

Placebo

Oral placebo, once a day, one tablet at a time for 6 months

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Ling Lv

Identifier Type: -

Identifier Source: org_study_id