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The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

Primary Purpose

NAFLD( Non-alcoholic Fatty Liver Disease )

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Chinese herb (YiQiSanJu)
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD( Non-alcoholic Fatty Liver Disease )

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Chinese herb

    Arm Description

    Chinese herb

    Outcomes

    Primary Outcome Measures

    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 .

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 28, 2012
    Last Updated
    September 4, 2012
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01677325
    Brief Title
    The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
    Official Title
    The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NAFLD( Non-alcoholic Fatty Liver Disease )

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Chinese herb
    Arm Type
    Experimental
    Arm Description
    Chinese herb
    Intervention Type
    Drug
    Intervention Name(s)
    Chinese herb (YiQiSanJu)
    Other Intervention Name(s)
    YiQiSanJu Formula
    Intervention Description
    Chinese herb formula:Huangqi,huanglian,yinchen,ect
    Primary Outcome Measure Information:
    Title
    The CT ratio of liver/spleen
    Description
    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 .
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    BMI(Body Mass Index )
    Description
    Body Mass Index,(weight/height^2)
    Time Frame
    12 weeks
    Title
    liver function
    Description
    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)
    Time Frame
    12 weeks
    Title
    lipid profile
    Description
    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)
    Time Frame
    12 weeks
    Title
    NEFA(nonesterified fatty acid)
    Description
    Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)
    Time Frame
    12 weeks
    Title
    HOMA index
    Description
    HOMA index(FBG*INSULIN/22.5)
    Time Frame
    12 weeks
    Title
    adiponectin
    Description
    adiponectin(pg/ml,Enzyme-linked immunosorbent assay)
    Time Frame
    12 weeks
    Title
    IL-6(interleukin 6)
    Description
    interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)
    Time Frame
    12 weeks
    Title
    hs-CRP (C-reactive protein)
    Description
    high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)
    Time Frame
    12 weeks
    Title
    TNFα( tumor necrosis factor-α)
    Description
    tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)
    Time Frame
    12 weeks
    Title
    leptin
    Description
    leptin(ng/ml,Enzyme-linked immunosorbent assay)
    Time Frame
    12 weeks
    Other Pre-specified Outcome Measures:
    Title
    renal function
    Description
    creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer)
    Time Frame
    12 weeks
    Title
    Routine blood
    Description
    automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:％.
    Time Frame
    12 weeks
    Title
    Routine urine examination
    Description
    automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-).
    Time Frame
    12 weeks
    Title
    Routine stool examination
    Description
    automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-)
    Time Frame
    12 weeks
    Title
    electrocardiography
    Description
    automatic electrocardiograph machine
    Time Frame
    12 weeks
    Title
    chest x-ray check
    Description
    diagnostic X-ray apparatus
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wen-Jian Wang, Ph.D,MD
    Organizational Affiliation
    Huashan Hospital, affliated to Fudan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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