Analysis of Clinical Characteristics of Chronic Hepatitis B Combined With MAFLD in Different TCM Syndrome Types

NCT07730736 | Completed

• 1 other identifier: FSTCM-20260719-003
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis B; Metabolic Associated Fatty Liver Disease

Keywords

Chronic Hepatitis B; MAFLD; Traditional Chinese Medicine Syndrome; Liver Fibrosis; Retrospective Study

Outcome Measures

Primary Outcomes (1)

• Liver stiffness measurement (LSM) value

  Retrospectively collect liver stiffness measurement (LSM) data of patients diagnosed with chronic hepatitis B combined with metabolic associated fatty liver disease. We compare the differences in the degree of liver fibrosis among five different traditional Chinese medicine syndrome types.

  Baseline

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This single-center retrospective observational study plans to enroll 1000 eligible subjects from the Hepatology Department of Foshan Hospital of Traditional Chinese Medicine. All participants are aged between 18 and 70 years old, with both male and female patients included. Subjects must meet the diagnostic criteria of chronic hepatitis B combined with metabolic associated fatty liver disease (CHB+MAFLD). Experienced TCM physicians classify all enrolled patients into five syndrome types via four diagnostic methods: spleen damp-heat syndrome, liver depression and spleen deficiency syndrome, spleen deficiency and phlegm-damp syndrome, damp-heat accumulation syndrome, and damp-heat blood stasis syndrome. No drug intervention or additional invasive examinations will be performed. We retrospectively extract routine inpatient and outpatient medical records, including demographic data, liver function indexes, metabolic biomarkers, liver stiffness measurement (LSM), controlled attenuation para

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foshan Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Foshan Hospital of Traditional Chinese Medicine

Foshan, Guangdong, 528000, China

Location

Related Publications (1)

• Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.

  PMID: 32044314 RESULT

MeSH Terms

Conditions

Hepatitis B, Chronic; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Hepatology

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start: March 5, 2025
• Primary Completion: October 31, 2025
• Study Completion: May 31, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)