Metabolic Dysfunction-Associated Fatty Liver Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)Patients meeting the diagnostic criteria for Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) with a predominant Phlegm-Dampness Constitution (as defined by TCM body constitution assessment); (2)Aged 18–65 years; (3)No participation in any drug clinical trials within the 3 months prior to enrollment; (4)Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: (1)Patients with a history of diabetes mellitus >5 years and/or current use of glucose-lowering medications; (2) Use of antibiotics probiotics antitumor agents or immunosuppressive drugs within the preceding 1 month; (3) Active oral pathologies including but not limited to acute/chronic periodontitis pulpitis oral neoplasms or cysts; (4)Diagnosis of gout or hyperuricemia (serum uric acid [UA] =540 µmol/L); (5)Special populations: Pregnant or lactating women or individuals with psychiatric disorders; (6)Patients with significant gastrointestinal disorders; (7)Concurrent severe systemic diseases including malignancies active infections immune disorders hematopoietic diseases or other major comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Mass Index;Fasting insulin;Serum Lipids(TC\TG\LDL-C\HDLC);waist circumference;Traditional Chinese Medicine Syndrome Pattern Score;Liver Ultrasound;glycosylated hemoglobin;Traditional Chinese Medicine Constitution Scoring System;liver function(ALT\AST);Fasting blood glucose;Homeostasis Model Assessment of Insulin Resistance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Renal function(Creatinine\Blood Urea Nitrogen\Glomerular filtration rate);transforming growth factor-ß;Tumor Necrosis Factor-alpha;short-chain fatty acid;Stool gut microbiota detection;Interleukin 10;interleukin-6;Human IL-1 beta protein; | — |
Countries
China
Contacts
People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine