The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

Fudan University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

NAFLD( Non-alcoholic Fatty Liver Disease )

Interventions

Chinese herb (YiQiSanJu)DRUG

Chinese herb formula:Huangqi,huanglian,yinchen,ect

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 .

Time frame: 12 weeks

Secondary Outcomes

BMI(Body Mass Index )

Body Mass Index,(weight/height\^2)

Time frame: 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)

Time frame: 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)

Time frame: 12 weeks

NEFA(nonesterified fatty acid)

Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)

Time frame: 12 weeks

HOMA index

HOMA index(FBG\*INSULIN/22.5)

Time frame: 12 weeks

adiponectin

adiponectin(pg/ml,Enzyme-linked immunosorbent assay)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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