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NCT07730736

Overview

NCT ID: NCT07730736
Lead Sponsor: Foshan Hospital of Traditional Chinese MedicineOTHER
Official Title: Analysis of Clinical Characteristics of Chronic Hepatitis B Virus Infection Complicated With Metabolic Associated Fatty Liver Disease Among Patients With Different Traditional Chinese Medicine Syndrome Types: A Retrospective Observational Study
Brief Summary: This is a retrospective cross-sectional observational clinical study. We will collect clinical medical records of patients diagnosed with chronic hepatitis B combined with metabolic associated fatty liver disease who received treatment at Foshan Hospital of Traditional Chinese Medicine. The main purpose is to explore the characteristics of renal function related indicators in these patients, analyze the influencing factors of early renal tubular injury caused by long-term antiviral therapy, and summarize the clinical correlation between liver metabolic abnormalities and early kidney damage. No additional invasive examinations or intervention measures will be performed on patients; only existing historical inpatient and outpatient medical data will be sorted out and statistically analyzed. All personal privacy information of subjects will be strictly desensitized and protected throughout the study

Status and Timeline

Status: Completed
Last Update Posted: Jul 28, 2026Actual
Start Date: Mar 5, 2025Actual
Primary Completion Date: Oct 31, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Aged between 18 and 70 years old, male and female patients are both eligible.

Meet the diagnostic criteria of chronic hepatitis B (CHB): HBsAg positive for more than 6 months, detectable HBV DNA, accompanied by abnormal liver function, hepatic inflammation or liver fibrosis, and other liver diseases are excluded.

Diagnosed with metabolic associated fatty liver disease (MAFLD) confirmed by imaging examination (ultrasound, CT or MRI) with hepatic steatosis ≥5%; patients meet at least one metabolic abnormality standard: BMI ≥25kg/m², fasting glucose ≥5.6mmol/L or type 2 diabetes, hypertension, dyslipidemia; patients without other etiologies of liver injury such as alcoholic liver disease and drug-induced liver injury.

Classified into 5 TCM syndrome types by experienced physicians through four diagnostic methods: spleen damp-heat syndrome, liver depression and spleen deficiency syndrome, spleen deficiency and phlegm-damp syndrome, damp-heat accumulation syndrome, damp-heat blood stasis syndrome.

Patients fully understand the study content and voluntarily sign the written informed consent form.

Complete clinical laboratory, imaging and four-diagnosis record data available for retrospective analysis.

Exclusion Criteria:

Patients with decompensated cirrhosis (Child-Pugh grade C) or liver failure.

Complicated with end-stage renal disease, malignant tumors, severe cardiovascular diseases and other severe systemic diseases.

Pregnant or lactating women.

Patients with mental disorders who cannot cooperate with data collection and clinical evaluation.

Long-term users of immunosuppressants.

Patients with incomplete medical records that cannot support complete index analysis.

Patients with other confounding liver diseases interfering with the judgment of MAFLD and CHB.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 1,000Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Foshan Hospital of Traditional Chinese Medicine

Similar Studies

Participant Group/Arms

Spleen Deficiency & Damp-Heat Syndrome

Cohort consists of patients diagnosed with chronic hepatitis B combined with metabolic associated fatty liver disease (MAFLD), who are differentiated as spleen deficiency and damp-heat type by traditional Chinese medicine standards. No interventional treatment was applied; clinical laboratory indicators, liver fibrosis and metabolic profiles were retrospectively collected for comparative analysis among all TCM syndrome groups.

Liver Depression & Spleen Deficiency Syndrome

This cohort includes CHB combined MAFLD patients with TCM differentiation of liver depression and spleen deficiency syndrome. This is a retrospective observational group without any therapeutic intervention. Baseline liver function, uric acid, renal tubular biomarkers and liver elasticity data were extracted for cross-group comparison.

Spleen Deficiency & Phlegm-Damp Syndrome

Enrolled patients suffering from chronic hepatitis B and metabolic fatty liver disease, categorized into spleen deficiency and phlegm-damp TCM syndrome. The study only collected historical medical record data without drug intervention, to explore differences in hepatic and metabolic characteristics across different syndrome types.

Internal Accumulation of Damp-Heat Syndrome

Subjects are CHB complicated with MAFLD patients meeting damp-heat accumulation TCM diagnostic criteria. It is a retrospective non-interventional cohort; all clinical data were obtained from archived inpatient and outpatient medical records for statistical comparison.

Damp-Heat & Blood Stasis Obstruction Syndrome

The cohort comprises patients with chronic hepatitis B and metabolic fatty liver disease diagnosed as damp-heat binding blood stasis syndrome via TCM differentiation. No treatment intervention was conducted in this study, and retrospective data collection was performed to analyze liver injury and renal early damage differences among five syndrome groups.