The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01677325
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : September 5, 2012
Information provided by (Responsible Party):
Wen-Jian Wang, Fudan University

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

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

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  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
Study Start Date : January 2007
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Experimental: Chinese herb
Chinese herb
Drug: Chinese herb (YiQiSanJu)
Chinese herb formula:Huangqi,huanglian,yinchen,ect
Other Name: YiQiSanJu Formula

Primary Outcome Measures :
  1. The CT ratio of liver/spleen [ Time Frame: 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 :
  1. BMI(Body Mass Index ) [ Time Frame: 12 weeks ]
    Body Mass Index,(weight/height^2)

  2. liver function [ Time Frame: 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)

  3. lipid profile [ Time Frame: 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)

  4. NEFA(nonesterified fatty acid) [ Time Frame: 12 weeks ]
    Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)

  5. HOMA index [ Time Frame: 12 weeks ]
    HOMA index(FBG*INSULIN/22.5)

  6. adiponectin [ Time Frame: 12 weeks ]
    adiponectin(pg/ml,Enzyme-linked immunosorbent assay)

  7. IL-6(interleukin 6) [ Time Frame: 12 weeks ]
    interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)

  8. hs-CRP (C-reactive protein) [ Time Frame: 12 weeks ]
    high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)

  9. TNFα( tumor necrosis factor-α) [ Time Frame: 12 weeks ]
    tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)

  10. leptin [ Time Frame: 12 weeks ]
    leptin(ng/ml,Enzyme-linked immunosorbent assay)

Other Outcome Measures:
  1. renal function [ Time Frame: 12 weeks ]
    creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer)

  2. Routine blood [ Time Frame: 12 weeks ]
    automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:%.

  3. Routine urine examination [ Time Frame: 12 weeks ]
    automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-).

  4. Routine stool examination [ Time Frame: 12 weeks ]
    automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-)

  5. electrocardiography [ Time Frame: 12 weeks ]
    automatic electrocardiograph machine

  6. chest x-ray check [ Time Frame: 12 weeks ]
    diagnostic X-ray apparatus

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01677325

Sponsors and Collaborators
Fudan University
Principal Investigator: Wen-Jian Wang, Ph.D,MD Huashan Hospital, affliated to Fudan University

Responsible Party: Wen-Jian Wang, Professor, Fudan University Identifier: NCT01677325     History of Changes
Other Study ID Numbers: 2006-65
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases