Post-Hepatitis B Liver Cirrhosis
Conditions
Interventions
Intervention group:TAF with the Modified Rou Gan San Jie Fang
Control group:TAF with the chinese herbal placebo (at 1/10 the dosage of the Modified Rou Gan San Jie Fang)
Sponsors
Yueyang Hospital of Integrated Traditional Chinese Medicien and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the Western medical diagnostic criteria for the compensated stage of post-Hepatitis B liver cirrhosis and the Chinese medical diagnostic criteria for 'Fu Xie Yu Jie' syndrome. The diagnostic criteria for Western medicine are based on the revised 2022 "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" and the revised 2020 "Primary Care Guidelines for Chronic Hepatitis B": Pathological diagnosis is confirmed when criteria (1) and (2) are met, and clinical diagnosis is confirmed when criteria (1) and (3) are met. (1) History and blood tests indicate current HBV infection (HBsAg positive), or a clear history of chronic HBV infection (previous HBsAg positive for more than 6 months, currently HBsAg negative, anti-HBc positive) with other causes excluded. (2) Liver biopsy pathology showing evidence of cirrhosis. (3) Meets at least two of the following five criteria and non-cirrhotic portal hypertension is excluded: ? Imaging shows evidence of cirrhosis and/or portal hypertension. ? Endoscopy shows esophageal and gastric varices. ? Liver transient elastography (TE) shows liver stiffness consistent with cirrhosis. ? Blood biochemical tests show reduced albumin levels (3 s compared to control). ? Peripheral blood routine examination shows platelet count <100×10^9/L. The diagnostic criteria for Traditional Chinese Medicine (TCM) refer to the "TCM Syndrome Differentiation Criteria for Viral Hepatitis" and the "Consensus on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Liver Cirrhosis" to establish the syndrome of latent pathogen and blood stasis obstruction: Clinical manifestations: Bitter and sticky taste in the mouth, discomfort in the hypochondrium, fullness in the epigastrium and abdomen, poor appetite, yellow urine, sticky stool, red tongue with white or yellow greasy coating, mildly congested sublingual veins, wiry and slippery pulse. Main symptoms:? Bitter and sticky taste in the mouth;? Discomfort in the hypochondrium;? Fullness in the epigastrium and abdomen. Secondary symptoms:? Yellow urine;? Sticky stool;? Poor appetite;? Heaviness and easy fatigue. Tongue and pulse: Red tongue edge, white or yellow greasy coating, mildly congested sublingual veins, wiry and slippery pulse. Differentiation criteria: (1) All main symptoms present indicate this syndrome; (2) Presence of two main symptoms and at least one secondary symptom, combined with tongue and pulse characteristics, also indicates this syndrome. 2. Age is between 18 and 80 years old, with no gender restrictions.
Exclusion criteria
Exclusion criteria: 1.Patients with post-Hepatitis B liver cirrhosis who also have other liver diseases such as hepatitis A, C, D, or E, autoimmune liver disease, or hereditary metabolic liver disease, or who have complications such as hepatic encephalopathy, refractory ascites, bleeding tendencies, hepatorenal syndrome, or primary liver cancer. 2.Patients with severe heart, lung, gallbladder, kidney, endocrine, hematopoietic system, and mental neurological diseases. 3.Individuals with allergic constitutions (those allergic to two or more drugs, foods, or pollen), or those who are known to be allergic to any of the ingredients of this medication. 4.Individuals who have participated in or are currently participating in other clinical trials within one month prior to enrollment. 5.Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver Stiffness Measurement;Hepatitis B Serological Markers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cirrhosis Diagnosis Model (AST to Platelet Ratio Index and Fibrosis-4 Index);Semi-quantitative Color Doppler Ultrasonography Scoring;Hepatitis B Virus DNA Viral Load;Liver Function;Coagulation Function;Liver Fibrosis Panel;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactJianyi Wang
Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed