Non-alcoholic simple fatty liver disease
Conditions
Interventions
Treatment group:Baobao Dan Capsules
Control group:Baobu Dan Capsules - Simulated Medicine
Sponsors
Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the Western medical diagnosis criteria for non-alcoholic simple fatty liver (NAFL) and whose TCM syndrome type conforms to the syndrome of damp-heat accumulation (refer to Appendix 1); 2. No gender restrictions; Age = 18 years and = 70 years; BMI 238 dB/m), and abdominal B-ultrasound suggested fatty liver. 4. Serological aspect: There is one or more abnormalities in blood lipids (TG, TC, HDL-C, LCL-C); liver function is normal. 5. The researchers determined that for patients who do not require lifestyle education, and who do not need other lipid-lowering medications such as statins, or who choose not to take such medications. 6. Can understand the research content, voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Clearly identify those individuals who have specific conditions that can lead to fatty liver, such as viral hepatitis, alcoholic liver disease, hepatolenticular degeneration, autoimmune liver disease, drug-induced liver disease, hypothyroidism, Cushing's syndrome, beta-lipoprotein deficiency, lipodystrophic diabetes, total parenteral nutrition, and malnutrition; 2. Patients with severe liver and kidney dysfunction, cardiovascular and cerebrovascular diseases, severe uncontrolled infections, severe electrolyte imbalances, active disseminated intravascular coagulation, and coagulation disorders were considered unsuitable for inclusion by the researchers. 3. History of liver transplantation, awaiting liver transplantation or current Model for End-Stage Liver Disease (MELD) score = 15; portal hypertension with complications; 4. Including gastric or large esophageal varices, refractory or diuretic-resistant ascites, history of variceal bleeding, history of variceal treatment such as use of beta-blockers, endoscopic tissue glue injection or ligation, transjugular portosystemic shunt, or hepatic encephalopathy; non-alcoholic fatty liver disease, liver cirrhosis, and liver cancer stage; hepatorenal syndrome (Type I or II) or screening serum creatinine (Cr) = 1.5×ULN and serum creatinine clearance rate < 60 mL/min; liver dysfunction decompensation (Child-Pugh classification B/C). 5. Having a history of malignant tumors in the past 5 years, regardless of whether treatment was received or whether there were local recurrence or metastasis evidence. 6. In addition to obesity and hyperlipidemia, those with a history of related metabolic syndrome conditions such as diabetes, impaired glucose tolerance, hyperuricemia, gout, and unstable hypertension; 7. Those who received traditional Chinese medicine or Chinese patent medicine with heat-clearing, dampness-resolving and fire-lowering effects within 30 days before the treatment, and who have taken weight-loss, lipid-lowering related drugs or health supplements with related auxiliary therapeutic effects; patients who have long consumed herbal cool teas or tonics containing Chinese herbs. 8. Patients who are currently undergoing treatment with heparin, thyroxine, and other drugs that affect fat metabolism; 9. Pregnant women, women planning pregnancy, and lactating women, during the study period and within 30 days after the last medication administration, who have the ability to reproduce but are unwilling to use effective contraceptive measures (at least one effective contraceptive method such as condoms, hormonal contraceptives, intrauterine devices). 10. Those with infectious diseases such as HIV and syphilis; 11. Those with any other diseases or conditions that interfere with the absorption, distribution, metabolism or excretion of the drug (such as those with inflammatory bowel disease or those who have undergone gastric bypass surgery); 12. Persons without the capacity for civil conduct, those with unstable mental states or those with restricted capacity for conduct; 13. For those who are allergic to the prescribed medications and their ingredients during the relevant trial observation period, such as the Baobao Dan Capsules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Based on the CT scan ratio of liver to spleen, the efficacy of Baobangdan Capsules in treating NAFL (with damp-heat accumulation syndrome) was evaluated.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The CAP value of liver transient elastography is used to evaluate the therapeutic efficacy of NAFL treatment.;Abdominal ultrasound examination is used to assess the effectiveness of NAFL treatment.;Improvement in blood lipid levels (TG, TC, HDL, LDL);;Evaluation of therapeutic effects of traditional Chinese medicine syndromes;Incidence and rate of adverse events; | — |
Countries
China
Contacts
Public ContactLiang Peng
Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed