Primary biliary cholangitis Autoimmune hepatitis
Conditions
Interventions
PBC Treatment group:Xiangubenpeiyuan bushenrougan Recipe Combined first-line therapeutic drugs
PBC Control group:Placebo combined with first-line therapeutic drugs
AIH Treatment group:Xiangubenpeiyuan shuganjianpi Recipe Combined first-line therapeutic drugs
AIH Control group:Placebo combined with first-line therapeutic drugs
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Primary biliary cholangitis: 1.Patients meeting the diagnostic criteria for Primary biliary cholangitis; 2.Patients meeting the TCM syndrome differentiation for liver and kidney Yin deficiency and blood stasis blocking collaterals; 3.The age ranges from 18 to 65 years, with no gender limitation; 4.Signing an informed consent. Autoimmune hepatitis: 1.Patients meeting the diagnostic criteria for Autoimmune hepatitis; 2.Patients meeting the TCM syndrome differentiation for Liver depression and spleen deficiency; 3.The age ranges from 18 to 65 years, with no gender limitation; 4.Signing an informed consent.
Exclusion criteria
Exclusion criteria: (1) Drug induced liver injury, viral hepatitis (hepatitis A, B, C, E), etc.; (2) Patients with severe primary disease of heart, brain, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract, or psychiatric patients; (3) Creatinine (Cr) greater than the upper limit of normal; (4) Use drugs to lose weight; (5) alcoholics or drug addicts; (6) Pregnant women, breastfeeding women or those who plan to become pregnant in the near future and those who use estrogen contraception; (7) Allergic constitution and allergy to multiple drugs, as well as the composition of this decoction or its ingredients (8) patients who are critically ill and difficult to accurately evaluate the effectiveness and safety of this decoction (9) The patient is unwilling to cooperate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fibroscan;MRE;Blood routine;Four hepatic fibrosis tests;Immunological tests;Traditional Chinese medicine syndrome score scale; | — |
Countries
China
Contacts
Public ContactGao Yueqiu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed