Non-alcoholic steatohepatitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meet the Western medicine diagnostic criteria for NASH; 2) Meet the traditional Chinese medicine diagnostic criteria for phlegm-turbidity internal obstruction and dampness-heat stasis binding syndrome; 3) Age between 18 and 65 years; 4) No treatment with the same category of medication within two weeks prior to the trial (excluding NASH patients already taking antihypertensive or lipid-lowering drugs); 5) Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with weekly ethanol consumption between moderate and excessive levels, in whom the etiology of abnormal liver enzymes and fatty liver is difficult to determine; 2) Patients with non-NASH fatty liver disease (e.g., acute fatty liver of pregnancy, fatty liver syndrome with encephalopathy, lipid storage diseases, hepatic fatty tumors, alcoholic liver disease, viral hepatitis-associated fatty liver, etc.); 3) Patients with severe pathologies of major organs such as the brain or kidneys, or with psychiatric disorders; 4) Patients with hypertension or hyperlipidemia who are already undergoing treatment; 5) Pregnant or lactating women; 6) Patients who have used other medications for NASH within two weeks prior to screening; 7) Individuals with allergic constitutions, or those allergic to any known component or excipient of the investigational drug; 8) Patients with a history of drug abuse; 9) Individuals who have participated in other clinical trials within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver enzymology;Blood lipid;Liver fat attenuation parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal B-ultrasound;Therapeutic effects of syndromes in traditional Chinese medicine; | — |
Countries
China
Contacts
Shenzhen Bao 'an District Hospital of Traditional Chinese Medicine