Metabolic related fatty liver disease
Conditions
Interventions
Experimental group:Hugan Buzu heat granules taken with boiling water 1 bag at a time 3 times a day
Qianggan capsule placebo 5 capsules a time 2 times a day 6 days per day stop for 1 day every 8 weeks stop for 1 week.
Contorl group:Hugan Buzu heat granule placebo, taken with boiling water, 1 bag at a time, 3 times a day
Qianggan capsule, 5 capsules at a time, 2 times a day, 6 days per day stop 1 day, every 8 weeks stop 1 week.
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Those who meet all of the following criteria are eligible for inclusion in this trial: (1) Age 18-65 years old including boundary values regardless of gender; (2) Meet the diagnostic criteria for metabolically related fatty liver disease in the Guidelines for the Prevention and Treatment of Metabolically Related (Non-alcoholic) Fatty Liver Disease; (3) Advanced liver fibrosis was excluded by Agile3+ assessment and the exclusion threshold of Agile3+ was < 0.451; (4) TCM syndrome differentiation conforms to liver-stagnation and spleen-deficiency syndrome; (5) Subjects voluntarily sign informed consent to participate in the experiment.
Exclusion criteria
Exclusion criteria: Any of the following are excluded from this study: (1) Patients with bulla fatty liver disease caused by drugs and toxic liver disease (environmental toxins ethamiodarone methotrexate 5-fluorouracil irinotecan tamoxifen glucocorticoids etc.) malnutrition genotype 3 HCV infection hepatolenticular degeneration hypoß-lipoproteinemia congenital lipid atrophy wheat bowel disease and other specific causes; (2) Other liver and gallbladder diseases suspected by medical history laboratory tests and imaging to affect the efficacy or safety evaluation of the investigational drug including but not limited to: Hepatitis virus infection alcoholic liver disease drug-induced liver disease autoimmune hepatitis cirrhosis primary sclerosing cholangitis a1-antitrypsin deficiency schistosomiasis liver disease liver cancer (or family history of liver cancer) etc. (3) Myocardial infarction unstable angina pectoris or coronary interventional therapy (permitting diagnostic angiography) or vessel transplantation or NYHA level III or above had occurred within 6 months prior to screening; (4) Complicated with severe blood system (various severe anemia hemophilia etc.) kidney disease (chronic kidney disease renal insufficiency etc.) respiratory system (active tuberculosis serious lung infection etc.) digestive system (active digestive ulcer refractory colitis etc.) nervous system and other primary diseases malignant tumors and mental illness (including a history of mental illness or mental illness Family history); (5) Combined with or prior to ascites varicose bleeding hepatic encephalopathy spontaneous bacterial peritonitis or liver transplantation or plans to undergo liver transplantation; (6) Blood creatinine = 1.5 times the upper limit of normal value; (7) Patients with prediabetes or type 2 diabetes mellitus were defined as fasting blood glucose =6.1mmol/L or 2h post-glucose load blood glucose =7.8mmol/L or HbA1c=5.7% or type 2 diabetes history or HOMA-IR=2.5; (8) Patients who have a history of bariatric surgery or plan to undergo bariatric surgery (within 1 year) and have used drugs with weight loss effects such as GLP-1 and orlistat within 4 weeks; (9) Patients who took lipid-lowering drugs (such as statins Bates niacin colestenamine high-purity fish oil preparations etc.) within 3 months before randomization and still had unstable and abnormal lipid control; (10) Liver protection drugs (including but not limited to reduced glutathione glucalactone glycyrrhizin preparation niacinamide biphenyl diester liver protection tablets silymarin (bin) polyene phosphatidylcholine S-adenosine methionine ursodeoxycholic acid vitamin E and other Chinese herbs that affect liver function etc.) were used within 4 weeks before inclusion; (11) There are contraindications in MRI scanning including but not limited to: Severe claustrophobia inner ear implants pacemakers or other implanted cardiac rhythm management devices intracranial aneurysm clips incompatible with MRI any other metal non-MMRI compatible implant devices (e.g. insulin pumps hip replacement) history of intraorbital metal fragments that have not been removed weight or waist circumference that exceeds the scanner function etc.; (12) known allergy to the components of the drug covered by the study; (13) Pregnant and lactating women and patients who refused to use contraception throughout the study; (14) Participants who have participated in other clinical trials in the past 3 months or are participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI-PDFF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life scale score;Agile3+ score;FibroScan-AST (FAST) Score;Fibrosis 4 Score;CAP;LSM;APRI;EQ-5D-5L scale score;Blood glucose related index;TCM syndrome score;Blood pressure, Uric acid;BMI, waist-to-hip ratio;Liver function index(ALTASTGGT);Lipid-related index(TCTGLDL-CHDL-C); | — |
Countries
China
Contacts
Public ContactSun Xuehua
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed