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NCT07730736Completed

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

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

Source: ClinicalTrials.gov · Last updated 28 Jul 2026

Brief summary (registry, in English)

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 (registry)
Completed
Study type
Observational
Enrollment
1000 (actual)
First submitted
22 Jul 2026
Start date
5 Mar 2025
Primary completion date
31 Oct 2025
Lead sponsor
Foshan Hospital of Traditional Chinese Medicine
NCT number
NCT07730736

What you commit to

  • Study type: Observational
  • Participants enrolled: 1000
  • From 5 Mar 2025 to the primary completion date, 31 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • Patients with mental disorders who cannot cooperate with data collection and clinical evaluation.
  • Patients with other confounding liver diseases interfering with the judgment of MAFLD and CHB.

Other

  • Pregnant or lactating women.
  • Long-term users of immunosuppressants.
  • Patients with incomplete medical records that cannot support complete index analysis.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Foshan Hospital of Traditional Chinese Medicine
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FoshanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.