A multicenter, randomized, double-blind, Tiaomian I study of PBC
- Conditions
- Primary biliary cholangitis
- Registration Number
- ITMCTR2000004009
- Lead Sponsor
- onghua Hospital ShangHai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Newly treated patients who meet the diagnostic criteria of primary biliary cholangitis in western medicine;
(2) Liver function ALT and AST <= 4ULN, TBIL <= 2ULN;
(3) Meet the diagnostic criteria of TCM qi deficiency and blood stasis syndrome;
(4) Male and female patients >= 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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method renal function;M2 antibodies;IL-6;Liver function;
- Secondary Outcome Measures
Name Time Method