Clinical Study on Qinghua Decoction to Reduce the Risk of Coronary Artery Disease in Patients with NAFLD with Turbid Phlegm and Internal Resistance
- Conditions
- onalcoholic fatty liver disease
- Registration Number
- ITMCTR2000003628
- Lead Sponsor
- onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Carotid ultrasound;Retinol binding protein 4;Cyclophilin A;Fibroscan;Liver ultrasound;Insulin Growth Factor-1;
- Secondary Outcome Measures
Name Time Method 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;