chronic hepatitis B virus infection and Fatty Liver Disease (Non-alcoholic Origin)
Conditions
Interventions
Control group:placebo
Sponsors
Shanghai Changhai Hopsital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women aged =40 years and =70 years; 2. The measurement of hepatic fat content was conducted using Fibrotouch, Fat attenuation index (FAI)> 250dB/m;CAP quartile spacing (IQR) =40dB/m; 3. In line with the diagnosis of chronic hepatitis B infection, according to the chronic hepatitis B prevention and treatment guidelines (2015 version), HBsAg positive 6 months diagnosis; ALT < 2 times ULN (standard upper limit) 4. According to the consensus of TCM diagnosis and treatment experts for chronic hepatitis B (2012), TCM syndrome type was diagnosed as damp-heat accumulation syndrome, liver stagnation and qi stagnation syndrome, liver stagnation and spleen deficiency syndrome, blood stasis and obstruction of collaterals. 5. BMI=20 kg/m2=30 kg/m2 6. The lifestyle will not be changed deliberately after being included, and there is no need to diet or lose weight; 7. Informed consent, voluntary subjects, informed consent process in accordance with GCP regulations.
Exclusion criteria
Exclusion criteria: 1 History of alcohol use or recent (past 12 months) drug abuse ,Alcohol abuse is defined as men drink > 30g/d; Women > 20g/d or according to the judgment of investigators; 2 B ultrasonography showed obvious space-occupying lesions in the liver or AFP>50 g/L;Or patients with liver cirrhosis or liver tumor; 3 Severe liver injury and/or significant abnormal liver function defined as aspartic acid amintransferase >3 normal (ULN) and/or upper limit of alanine amintransferase >3 ULN.Or diagnosed as chronic severe hepatitis B or have a tendency to severe hepatitis; 4 Alcoholic liver disease, total parenteral nutrition, hepatolenticular degeneration, autoimmune liver disease, drug-induced liver disease and other specific diseases that may lead to fatty liver;Patients with chronic viral and non-viral hepatitis other than hepatitis B;Total bilirubin >2.0mg/dl(34.2 mol/l); 5 Patients with other serious diseases, such as severe heart, lung, kidney, endocrine, nervous and blood system diseases and mental diseases; 6 Patients with previous organ transplantation (such as liver, kidney, lung, heart, etc.), bone marrow transplantation or hematopoietic liver cell transplantation; 7 Received lipid-lowering or liver protection treatment 30 days before taking the medicine; Patients who need to take other drugs that may affect the efficacy or who are allergic to experimental drugs at the same time; 8 Other conditions that the researcher thinks should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Mass Index;liver function;Liver transient elasticity test;Blood lipid; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM symptom score; | — |
Countries
China
Contacts
Public ContactChangquan Ling
Shanghai University of Traditional Chinese Medicine
Outcome results
None listed