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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04727320
Enrollment
60
Registered
2021-01-27
Start date
2021-03-05
Completion date
2021-07-30
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

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.

Interventions

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

DRUGPlacebo

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

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Liver biopsyup to 24 weeksSynthesis of liver extracellular matrix(Synthesis, degradation)

Secondary

MeasureTime frameDescription
Liver ultrasoundup to 24 weeksLiver parenchymal echo(Normal, dense, thickened)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026