The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

Phase 1

Completed

• Conditions: NAFLD( Non-alcoholic Fatty Liver Disease )
• Interventions: Drug: Chinese herb (YiQiSanJu)

• Registration Number: NCT01677325
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2007-01
• Study Completion: 2008-01
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-31
• Status Verified: 2012-09
• Study First Posted: 2012-09-03
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chinese herb	Chinese herb (YiQiSanJu)	Chinese herb

Primary Outcome Measures

Name	Time	Method
The CT ratio of liver/spleen	12 weeks	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 .

Secondary Outcome Measures

Name	Time	Method
leptin	12 weeks	leptin(ng/ml,Enzyme-linked immunosorbent assay)
BMI(Body Mass Index )	12 weeks	Body Mass Index,(weight/height\^2)
liver function	12 weeks	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)
lipid profile	12 weeks	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)
NEFA(nonesterified fatty acid)	12 weeks	Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)
HOMA index	12 weeks	HOMA index(FBG\*INSULIN/22.5)
adiponectin	12 weeks	adiponectin(pg/ml,Enzyme-linked immunosorbent assay)
IL-6(interleukin 6)	12 weeks	interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)
hs-CRP (C-reactive protein)	12 weeks	high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)
TNFα( tumor necrosis factor-α)	12 weeks	tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)