The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wen-Jian Wang, Fudan University
ClinicalTrials.gov Identifier:
NCT01677325
First received: August 28, 2012
Last updated: September 4, 2012
Last verified: September 2012

August 28, 2012
September 4, 2012
January 2007
January 2007   (final data collection date for primary outcome measure)
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 .
The CT ratio of liver/spleen [ Time Frame: 12w ] [ 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 .
Complete list of historical versions of study NCT01677325 on ClinicalTrials.gov Archive Site
  • 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)
  • BMI(Body Mass Index ) [ Time Frame: 12w ] [ Designated as safety issue: No ]
    Body Mass Index,(weight/height^2)
  • liver function [ Time Frame: 12w ] [ 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: 12w ] [ 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: 12w ] [ Designated as safety issue: No ]
    Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)
  • HOMA index [ Time Frame: 12w ] [ Designated as safety issue: No ]
    HOMA index(FBG*INSULIN/22.5)
  • adiponectin [ Time Frame: 12w ] [ Designated as safety issue: No ]
    adiponectin(pg/ml,Enzyme-linked immunosorbent assay)
  • IL-6(interleukin 6) [ Time Frame: 12w ] [ Designated as safety issue: No ]
    interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)
  • hs-CRP (C-reactive protein) [ Time Frame: 12w ] [ Designated as safety issue: No ]
    high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)
  • TNFα( tumor necrosis factor-α) [ Time Frame: 12w ] [ Designated as safety issue: No ]
    tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)
  • leptin [ Time Frame: 12w ] [ Designated as safety issue: No ]
    leptin(ng/ml,Enzyme-linked immunosorbent assay)
  • 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
  • renal function [ Time Frame: 12w ] [ Designated as safety issue: Yes ]
    creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer)
  • Routine blood [ Time Frame: 12w ] [ Designated as safety issue: Yes ]
    automatic blood analyzer
  • Routine urine examination [ Time Frame: 12w ] [ Designated as safety issue: Yes ]
    automatic urine analyzer
  • Routine stool examination [ Time Frame: 12w ] [ Designated as safety issue: Yes ]
    automatic stool analyzer
  • electrocardiography [ Time Frame: 12w ] [ Designated as safety issue: Yes ]
  • chest x-ray check [ Time Frame: 12w ] [ Designated as safety issue: Yes ]
 
The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
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.

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
NAFLD( Non-alcoholic Fatty Liver Disease )
Drug: Chinese herb (YiQiSanJu)
Chinese herb formula:Huangqi,huanglian,yinchen,ect
Other Name: YiQiSanJu Formula
Experimental: Chinese herb
Chinese herb
Intervention: Drug: Chinese herb (YiQiSanJu)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2008
January 2007   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01677325
2006-65
Yes
Wen-Jian Wang, Fudan University
Fudan University
Not Provided
Principal Investigator: Wen-Jian Wang, Ph.D,MD Huashan Hospital, affliated to Fudan University
Fudan University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP