Nonalcoholic fatty liver disease
Conditions
Interventions
Control group:Basic treatment
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Men or women aged 40 to 75 years old. (2) Those who meet the diagnostic criteria for non-alcoholic fatty liver disease and the TCM syndrome diagnostic criteria for phlegm-turbid internal resistance syndrome. (3) Informed consent, patients voluntarily take the test; the process of obtaining informed consent should comply with GCP regulations. (4) Serum alanine aminotransferase (ALT) <= 2 times the upper limit of normal value, and total bilirubin (TBIL) <= 2 times the upper limit of normal value.
Exclusion criteria
Exclusion criteria: (1) Fatty liver, Reye syndrome fatty liver, ß-lipoprotein deficiency, and localized fatty liver caused by chronic heart failure, malnutrition and pregnancy. Patients with fatty liver caused by diabetes, long-term use of hormones, small bowel bypass surgery, toxic injury of liver cells, and chronic febrile diseases (such as tuberculosis, ulcerative colitis, chronic infection after gastrointestinal surgery, etc.). (2) Severe fatty liver with ascites, edema, hyponatremia and hypokalemia and other suspected liver cirrhosis; hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors. (3) Other Chinese and Western medicines for the treatment of fatty liver have been used after the onset. (4) Severe primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease, or serious disease that affects their survival, such as tumor or AIDS. (5) Patients with mental or legal disabilities. (6) Suspected or true history of alcohol or drug abuse, or other diseases that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator, such as frequent changes in the working environment, etc. that may easily cause loss to follow-up. (7) Those who are known to be allergic to the components of this medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carotid ultrasound;Retinol binding protein 4;Cyclophilin A;Fibroscan;Liver ultrasound;Insulin Growth Factor-1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alanine aminotransferase;Fasting blood glucose;Triglycerides;Fasting insulin;Glutamyl transpeptidase;Total cholesterol;TCM clinical efficacy index;Total bilirubin;Body Mass Index;Waist-to-Hip Ratio;Low-density lipoprotein;Insulin resistance index;Aspartate aminotransferase; | — |
Countries
China
Contacts
Public ContactLi Ying
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed