The multicenter clinical study of TCM in the prevention of HBV-related hepatic cirrhosis
- Conditions
- Macronodular cirrhosis after chronic hepatitis B
- Registration Number
- ITMCTR2000003700
- Lead Sponsor
- Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patients with chronic hepatitis B cirrhosis who meet the diagnostic criteria;
2. Hepatic regenerative nodules (>5 mm) were detected by Contrast enhanced ultrasound;
3. Aged 18 to 65 years;
4. Sign informed consent.
(1) Patients with cirrhosis caused by other hepatophilic virus infection or other pathogenic factors;
(2) The presence or suspected presence of primary hepatocellular carcinoma lesions was detected by B-mode ultrasonography or MRI;
(3) The patients with Child-Pugh C grade > 12 points, had upper gastrointestinal bleeding, hepatic encephalopathy and hepatorenal syndrome in the past six months;
(4) Patients with severe primary diseases of heart, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract; or psychiatric patients;
(5) Pregnant women or breast-feeding women who are willing to have children in the near future.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of primary liver cancer;Incidence of upper gastrointestinal hemorrhage, hepatic encephalopathy and hepatorenal syndrome;Incidence and mortality of severe hepatitis;
- Secondary Outcome Measures
Name Time Method Virological indicators;CBC;Liver function;Fibroscan;Contrast enhanced ultrasound;Alpha fetoprotein;TCM Syndrome Scale and Quality of Life Scale;