primary biliary cholangitis
Conditions
Interventions
Test group:Chaihubiejia decoction granules and ursodeoxycholic acid capsule
Control gruop:Compound Biejia Ruangan tablet and ursodeoxycholic acid capsule
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Age 18-75 years old gender is not limited; (2)All patients were diagnosed with primary biliary cirrhosis (dampness-heat syndrome of liver and gallbladder); (3)LSM=7.6Kpa; (4)Subject knows and voluntarily signs "Subject Informed Consent".
Exclusion criteria
Exclusion criteria: (1)Patients with other liver diseases such as viral liver disease and alcoholic liver disease; (2)People with infectious and other autoimmune liver diseases; (3)Contraindications with ursodeoxycholic acid capsules include acute cholecystitis and cholangitis biliary obstruction recurrent biliary colic attacks calcification of radio-impervious gallstones impaired gallbladder function and gallbladder inability to be seen on X-rays; (4)Patients with INR > 1.5 or PTA= 40% were prone to bleeding; (5)Patients with rapid deepening of jaundice in the past two weeks and serum TBil=10×ULN or daily increase =17.1µmol/L; (6)Patients with AST or ALT > 3 times the upper limit of normal; (7)In other clinical trials; (8)Allergic to the investigational drug; (9)Can not cooperate with the scale data collection; (10)Prepare for pregnancy, pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LSM; | — |
Secondary
| Measure | Time frame |
|---|---|
| APRI;the GLOBE score;Platelet count;Pro-C3;Aspartate Transaminase;TGF-ß;Modified Fatigue Scale;MMP-9;Abdominal ultrasound points;Albumin;5-D Pruritus Dosage Table;Smad3;Four items of liver fibrosis;Score of traditional Chinese medicine syndrome scale;UK-PBC risk score;Fibrosis 4 Score;Alkaline phosphatase;TIMP-1;Alanine transaminase;?-glutamyl transpeptidase;white blood cell count; | — |
Countries
China
Contacts
Public ContactZhang Yinqiang
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed