| Registry | NCT04727320 |
|---|---|
| Status | Unknown |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University (Other) |
| Conditions | Liver Cirrhosis |
| Interventions | Tauroursodeoxycholic acid, Placebo (Drug) |
| Dates | start 2021-03-05 (estimated), primary completion 2021-07-30 (estimated), completion 2021-07-30 (estimated), first posted 2021-01-27, last updated 2021-03-09 |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| patient+TUDCA | Experimental | Drug: Tauroursodeoxycholic acid | |
| patient+placebo | Placebo comparator | Drug: Placebo |
Sex: All, ages: 30 Years to 60 Years
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.