Chronic Hepatitis BNCT07730736
Analysis of Clinical Characteristics of Chronic Hepatitis B Combined With MAFLD in Different TCM Syndrome Types
An observational study of Chronic Hepatitis B and Metabolic Associated Fatty Liver Disease, run by Foshan Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis B, Metabolic Associated Fatty Liver Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2025to 31 May 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, 528000
About this study
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
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
- Keywords
- Chronic Hepatitis B, MAFLD, Traditional Chinese Medicine Syndrome, Liver Fibrosis, Retrospective Study
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start5 Mar 2025
- Primary completion31 Oct 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foshan Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan haiyan, Foshan Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730736
- Sponsor's protocol ID
- FSTCM-20260719-003
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32044314