Clinical efficacy observation of TCM in the prevention and treatment of macronodular cirrhosis (precancerous lesions)
- Conditions
- macronodular cirrhosis
- Registration Number
- ITMCTR1900002313
- 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 (> 3 mm) were detected by B-mode ultrasonography and MRI.
3.Age ranges from 18 to 65 years, gender is not limited.
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 and MRI.
(3) The patients with decompensated cirrhosis, such as those with Child-Pugh C grade > 12 points, had upper gastrointestinal bleeding, hepatic encephalopathy, intractable ascites, hemorrhagic tendency, hepatorenal syndrome and primary hepatocellular carcinoma 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 and mortality of severe hepatitis;Incidence of primary liver cancer;Incidence of upper gastrointestinal hemorrhage, hepatic encephalopathy and hepatorenal syndrome;
- Secondary Outcome Measures
Name Time Method CBC;Virological indicators;Ultrasound/MRI of Upper Abdomen;TCM Syndrome Scale and Quality of Life Scale;Alpha fetoprotein;Fibroscan;Liver function;