NAFLD
Conditions
Interventions
Control group:basic treatment
Treatment group:Basic treatment + Spleen-strengthening and accumulation-eliminating formula
Sponsors
Shanghai Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Western medical diagnosis consistent with the criteria for non-alcoholic fatty liver disease (NAFLD). Comorbid glucose and lipid metabolism disorders, defined as: Glucose abnormalities: fasting blood glucose =6.1 mmol/L and/or 2-hour postprandial glucose =7.8 mmol/L; Lipid abnormalities: fasting triglyceride (TG) =1.70 mmol/L and/or fasting high-density lipoprotein cholesterol (HDL-C) <1.04 mmol/L. TCM diagnosis consistent with the spleen deficiency and dampness obstruction syndrome according to TCM syndrome differentiation criteria. Age between 18–65 years old, regardless of gender. Voluntary participation and signed informed consent.
Exclusion criteria
Exclusion criteria: Patients with liver cirrhosis hepatocellular carcinoma severe diabetes mellitus or severe cardiovascular/cerebrovascular diseases. Patients who have taken other medications for NAFLD liver protection lipid-lowering glucose-lowering or weight-loss within 4 weeks prior to enrollment. Patients with comorbidities such as autoimmune hepatitis primary biliary cirrhosis drug/toxic hepatitis alcoholic liver disease or other conditions causing fatty liver. Pregnant or lactating women or women planning to become pregnant during the study period. Patients with severe primary diseases in the circulatory respiratory digestive or hematopoietic systems or life-threatening conditions (e.g. malignant tumors). Patients with mental disorders that prevent compliance with the study. Patients with an allergy-prone constitution or known allergy to components of the Jianpi Xiaoji Formula. Patients unable to comply with trial procedures or whose outcomes cannot be reliably evaluated for efficacy/safety. Patients participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnetic Resonance Imaging–Proton Density Fat Fraction;Controlled Attenuation Parameter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of traditional Chinese medicine symptoms;Body Mass Index;Fasting Plasma Glucose, Fasting Insulin, Glycated Hemoglobin, Homeostasis Model Assessment of Insulin Resistance;Total Cholesterol, Triglyceride, High-Density Lipoprotein Cholesterol, Low-Density Lipoprotein Cholesterol; | — |
Countries
China
Contacts
Public ContactNIE HONGMING
Shanghai Traditional Chinese Medicine Hospital
Outcome results
None listed