A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis
- Conditions
- primary biliary cirrhosis
- Registration Number
- ITMCTR1900025303
- 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) signing the informed consent;
(2) male or female aged 18-65 years;
(3) the syndrome differentiation of traditional Chinese medicine is liver kidney yin deficiency, blood stasis blocking collaterals;
(4) patients whose clinical diagnosis of Western medicine conforms to the PBC diagnostic standard and belongs to stage II and III;
(1) Combined with drug-induced liver injury, autoimmune hepatitis A, B, C, e, etc.;
(2) patients with serious primary diseases of heart, brain, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract, or psychosis;
(3) creatinine (CR) is higher than the upper limit of normal value;
(4) those who use drugs to lose weight;
(5) an alcoholic or drug addict;
(6) pregnant women, lactating women or those who prepare for pregnancy in the near future and those who use estrogen for contraception;
(7) those who are allergic to a variety of drugs, this medicine or its components;
(8) the patient is in critical condition, and it is difficult to make accurate evaluation on the effectiveness and safety of the new drug;
(9) patients are not willing to cooperate.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AMA;APRI;AMA-M2;Clinical symptom score ;Clinical efficiency;GLOBE-Score;Fibrotouch;Four items of liver fibrosis ;liver function;
- Secondary Outcome Measures
Name Time Method