The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine - Full Text View

Purpose

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

Condition	Intervention	Phase
NAFLD( Non-alcoholic Fatty Liver Disease )	Drug: Chinese herb (YiQiSanJu)	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:

The CT ratio of liver/spleen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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:

BMI(Body Mass Index ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Body Mass Index,(weight/height^2)
liver function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)
HOMA index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
HOMA index(FBG*INSULIN/22.5)
adiponectin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
adiponectin(pg/ml,Enzyme-linked immunosorbent assay)
IL-6(interleukin 6) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)
hs-CRP (C-reactive protein) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)
TNFα( tumor necrosis factor-α) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)
leptin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
leptin(ng/ml,Enzyme-linked immunosorbent assay)

Other Outcome Measures:

renal function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer)
Routine blood [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:％.
Routine urine examination [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-).
Routine stool examination [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-)
electrocardiography [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
automatic electrocardiograph machine
chest x-ray check [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
diagnostic X-ray apparatus

Enrollment:	40
Study Start Date:	January 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Chinese herb Chinese herb	Drug: Chinese herb (YiQiSanJu) Chinese herb formula:Huangqi,huanglian,yinchen,ect Other Name: YiQiSanJu 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677325

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:

Wen-Jian Wang, Ph.D,MD

Huashan Hospital, affliated to Fudan University

More Information

No publications provided

Responsible Party:	Wen-Jian Wang, Professor, Fudan University
ClinicalTrials.gov Identifier:	NCT01677325 History of Changes
Other Study ID Numbers:	2006-65
Study First Received:	August 28, 2012
Last Updated:	September 4, 2012
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:

Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013