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NCT04727320 Clinical Trial

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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04727320
Other study ID # Ling Lv
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date March 5, 2021
Est. completion date July 30, 2021

Study information
Verified date March 2021
Source The First Affiliated Hospital with Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tauroursodeoxycholic acid
Oral TUDCA, once a day, one tablet (250mg) at a time for 6 months
• Placebo
Oral placebo, once a day, one tablet at a time for 6 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary Liver biopsy Synthesis of liver extracellular matrix(Synthesis, degradation) up to 24 weeks
Secondary Liver ultrasound Liver parenchymal echo(Normal, dense, thickened) up to 24 weeks
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