metabolic-associated fatty liver disease
Conditions
Interventions
Chinese medicine treatment group:Lifestyle Improvement + Jianpi Tongluo Decoction
Western medicine control group:Lifestyle Improvement + Glucuronolactone Tablets
Sponsors
Beijing Children's Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
7 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1.Medical history = 6 months 2.Meeting the diagnostic criteria for pediatric metabolic-associated fatty liver disease (MAFLD) and TCM syndrome differentiation of "spleen deficiency with collateral stasis" 3.Alanine aminotransferase (ALT) above the normal range 4.Aged 7–16 years 5.No use of other Chinese or Western medications within 4 weeks prior to enrollment 6.The child or their legally authorized guardian fully understands and signs the informed consent form
Exclusion criteria
Exclusion criteria: 1.Fatty liver disease with dual/multiple etiologies or MAFLD complicated by other liver diseases including: a. Drug-induced liver injury (DILI) (e.g. due to herbal medicines or dietary supplements) b. Viral hepatitis (serologically or virologically confirmed) c. Autoimmune liver diseases including autoimmune hepatitis (AIH) primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) 2.Patients with concurrent malignancies or related chronic complications 3.Patients with severe systemic diseases affecting the cardiovascular cerebrovascular renal or hematopoietic systems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alanine aminotransferase; | — |
Secondary
| Measure | Time frame |
|---|---|
| Triglycerides;Body Fat Percentage;Glycated hemoglobin;Fasting Blood Glucose;Homeostasis model assessment of Insulin resistance;High density lipoprotein;Cholesterol;Intestinal flora;Traditional Chinese Medicine Syndrome Efficacy; | — |
Countries
China
Contacts
Public ContactQiang He
Beijing Children's Hospital Capital Medical University
Outcome results
None listed