The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

Study Overview
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Brief Summary
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To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.

Detailed Description
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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.

Official Title
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The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

Conditions
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NAFLD( Non-alcoholic Fatty Liver Disease )

Intervention / Treatment
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* Drug: Chinese herb (YiQiSanJu)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects with NAFLD(nonalcoholic fatty liver disease) (criteria of Society of Hepatology, Chinese Medical Association, 2002.10), aged 18-65 alcohol consumption less than 40g/week; liver/spleen (L/S) ratio no more than 1 by CT scan. Exclusion Criteria: ALT more than twice the upper end of the normal range viral hepatitis total parenteral alimentation or secondary liver disease such as hepatocirrhosis, autoimmune hepatitis, metabolic liver disease or drug induced liver disease severe cardiovascular or renal dysfunction Subjects with diabetes (fasting glucose more than or equal to 7.0mmol/L or postprandial glucose more than or equal to 11.1mmol/L) Subjects treated with statins

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese herb<br>Chinese herb | Drug: Chinese herb (YiQiSanJu)<br>* Chinese herb formula:Huangqi,huanglian,yinchen,ect<br>* Other names: YiQiSanJu Formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |