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To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.
1) Liver fat (measured by CT scan) and liver function assessed by liver enzymes levels; 2) Insulin sensitivity measured by HOMA index, oral glucose tolerance test (OGTT) and a euglycaemic hyperinsulinaemic clamp (with stable isotopes) in a subset of the subjects; 3) Plasma lipid profile and non esterified fatty acids (NEFA) concentration; 4) Circulating levels of adipokines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese herb | Experimental | Chinese herb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese herb (YiQiSanJu) | Drug | Chinese herb formula:Huangqi,huanglian,yinchen,ect |
|
| Measure | Description | Time Frame |
|---|---|---|
| The CT ratio of liver/spleen | CT imaging has been used to assess hepatic steatosis and has been validated in relation to liver biopsy .The ratio of liver to spleen (L/S ratio) for CT attenuation values is an index, with a L/S ratio<1 considered to represent fatty liver . | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BMI(Body Mass Index ) | Body Mass Index,(weight/height^2) | 12 weeks |
| liver function | Liver function enzymes- alanine aminotransferase (ALT,U/L), aspartate aminotransferase (AST,U/L) and γ-glutamyltransferase (GGT,U/L) and total bilirubin (TBI,μmol/L), albumin/globin (A/G)(Automatic biochemical analyzer) |
| Measure | Description | Time Frame |
|---|---|---|
| renal function | creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer) | 12 weeks |
| Routine blood | automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:％. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Jian Wang, Ph.D,MD | Huashan Hospital, affliated to Fudan University | Principal Investigator |
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| 12 weeks |
| lipid profile | Plasma lipids including triglyceride (TG,mmol/L), total cholesterol, low-density lipoprotein (LDL.mmol/L), high-density lipoprotein (HDL,mmol/L), apolipoprotein A (ApoA,mmol/L), apolipoprotein B (ApoB,mmol/L) and lipoprotein (a) (Lp(a),mmol/L). (Automatic biochemical analyzer) | 12 weeks |
| NEFA(nonesterified fatty acid) | Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay) | 12 weeks |
| HOMA index | HOMA index(FBG*INSULIN/22.5) | 12 weeks |
| adiponectin | adiponectin(pg/ml,Enzyme-linked immunosorbent assay) | 12 weeks |
| IL-6(interleukin 6) | interleukin 6(pg/ml,Enzyme-linked immunosorbent assay) | 12 weeks |
| hs-CRP (C-reactive protein) | high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay) | 12 weeks |
| TNFα( tumor necrosis factor-α) | tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay) | 12 weeks |
| leptin | leptin(ng/ml,Enzyme-linked immunosorbent assay) | 12 weeks |
| 12 weeks |
| Routine urine examination | automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-). | 12 weeks |
| Routine stool examination | automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-) | 12 weeks |
| electrocardiography | automatic electrocardiograph machine | 12 weeks |
| chest x-ray check | diagnostic X-ray apparatus | 12 weeks |