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A multicenter, randomized, double-blind, Tiaomian I study of PBC

A multicenter, randomized, double-blind, Tiaomian I study of PBC

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037244
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Primary biliary cholangitis

Interventions

Sponsors

Longhua Hospital ShangHai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Newly treated patients who meet the diagnostic criteria of primary biliary cholangitis in western medicine; (2) Liver function ALT and AST = 40 years old and <= 70 years old; (5) Decompensated liver cirrhosis with b-ultrasonography without portal hypertension and peritoneal effusion; (6) Patients who have signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Other chronic liver diseases such as viral liver disease, metabolic liver disease, alcoholic liver disease, drug liver disease, liver villous tumor, etc. (2) Child-pugh rating of > 9; (3) Pregnant or lactating women, women of childbearing age who do not use effective contraceptive methods (such as condoms, hormonal contraceptives, iUDS, abstinence) or male subjects who do not want to use contraceptive methods; (4) Persons with serious primary cardiovascular diseases, renal diseases, hematological diseases, lung diseases, tumors, AIDS and other serious diseases affecting their survival; For example: Abnormal renal function, creatinine higher than the upper limit of the normal value.Arrhythmias of clinical significance. (5) Having no capacity for civil conduct or limited capacity; (6) Suspect or have a history of alcohol or drug abuse; (7) Those who are known to be allergic to the composition of this drug; (8) Those who have participated in other clinical trials within 3 months before the trial; (9) The researcher considers it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Liver function;renal function;M2 antibodies;IL-6;

Countries

China

Contacts

Public ContactWei Zhang

Longhua Hospital ShangHai University of Traditional Chinese Medicine

18918104444@189.cn+86 18918104444

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026