The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

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

Study Overview

• Status: Completed
• Conditions: NAFLD( Non-alcoholic Fatty Liver Disease )
• Intervention / Treatment: Drug: Chinese herb (YiQiSanJu)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chinese herb	Drug: Chinese herb (YiQiSanJu); Chinese herb formula:Huangqi,huanglian,yinchen,ect; Other Names: YiQiSanJu Formula

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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:％.	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

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Wen-Jian Wang, Ph.D,MD, Huashan Hospital, affliated to Fudan University

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: August 31, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 4, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 2006-65