<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01677325</url>
  </required_header>
  <id_info>
    <org_study_id>2006-65</org_study_id>
    <nct_id>NCT01677325</nct_id>
  </id_info>
  <brief_title>The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine</brief_title>
  <official_title>The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a&#xD;
      Chinese herb formula.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1) Liver fat (measured by CT scan) and liver function assessed by liver enzymes levels; 2)&#xD;
      Insulin sensitivity measured by HOMA index, oral glucose tolerance test (OGTT) and a&#xD;
      euglycaemic hyperinsulinaemic clamp (with stable isotopes) in a subset of the subjects; 3)&#xD;
      Plasma lipid profile and non esterified fatty acids (NEFA) concentration; 4) Circulating&#xD;
      levels of adipokines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">January 2008</completion_date>
  <primary_completion_date type="Actual">January 2007</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The CT ratio of liver/spleen</measure>
    <time_frame>12 weeks</time_frame>
    <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&lt;1 considered to represent fatty liver .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI(Body Mass Index )</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body Mass Index,(weight/height^2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver function</measure>
    <time_frame>12 weeks</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lipid profile</measure>
    <time_frame>12 weeks</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NEFA(nonesterified fatty acid)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA index</measure>
    <time_frame>12 weeks</time_frame>
    <description>HOMA index(FBG*INSULIN/22.5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adiponectin</measure>
    <time_frame>12 weeks</time_frame>
    <description>adiponectin(pg/ml,Enzyme-linked immunosorbent assay)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6(interleukin 6)</measure>
    <time_frame>12 weeks</time_frame>
    <description>interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hs-CRP (C-reactive protein)</measure>
    <time_frame>12 weeks</time_frame>
    <description>high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNFα( tumor necrosis factor-α)</measure>
    <time_frame>12 weeks</time_frame>
    <description>tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>leptin</measure>
    <time_frame>12 weeks</time_frame>
    <description>leptin(ng/ml,Enzyme-linked immunosorbent assay)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>renal function</measure>
    <time_frame>12 weeks</time_frame>
    <description>creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer)</description>
  </other_outcome>
  <other_outcome>
    <measure>Routine blood</measure>
    <time_frame>12 weeks</time_frame>
    <description>automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:％.</description>
  </other_outcome>
  <other_outcome>
    <measure>Routine urine examination</measure>
    <time_frame>12 weeks</time_frame>
    <description>automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-).</description>
  </other_outcome>
  <other_outcome>
    <measure>Routine stool examination</measure>
    <time_frame>12 weeks</time_frame>
    <description>automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-)</description>
  </other_outcome>
  <other_outcome>
    <measure>electrocardiography</measure>
    <time_frame>12 weeks</time_frame>
    <description>automatic electrocardiograph machine</description>
  </other_outcome>
  <other_outcome>
    <measure>chest x-ray check</measure>
    <time_frame>12 weeks</time_frame>
    <description>diagnostic X-ray apparatus</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>NAFLD( Non-alcoholic Fatty Liver Disease )</condition>
  <arm_group>
    <arm_group_label>Chinese herb</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chinese herb</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chinese herb (YiQiSanJu)</intervention_name>
    <description>Chinese herb formula:Huangqi,huanglian,yinchen,ect</description>
    <arm_group_label>Chinese herb</arm_group_label>
    <other_name>YiQiSanJu Formula</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects with NAFLD(nonalcoholic fatty liver disease) (criteria of Society of&#xD;
             Hepatology, Chinese Medical Association, 2002.10),&#xD;
&#xD;
          -  aged 18-65&#xD;
&#xD;
          -  alcohol consumption less than 40g/week;&#xD;
&#xD;
          -  liver/spleen (L/S) ratio no more than 1 by CT scan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ALT more than twice the upper end of the normal range&#xD;
&#xD;
          -  viral hepatitis&#xD;
&#xD;
          -  total parenteral alimentation or secondary liver disease such as hepatocirrhosis,&#xD;
             autoimmune hepatitis, metabolic liver disease or drug induced liver disease&#xD;
&#xD;
          -  severe cardiovascular or renal dysfunction&#xD;
&#xD;
          -  Subjects with diabetes (fasting glucose more than or equal to 7.0mmol/L or&#xD;
             postprandial glucose more than or equal to 11.1mmol/L)&#xD;
&#xD;
          -  Subjects treated with statins&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Jian Wang, Ph.D,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huashan Hospital, affliated to Fudan University</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>September 4, 2012</last_update_submitted>
  <last_update_submitted_qc>September 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Wen-Jian Wang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01677325
org study id: 2006-65
nct id: NCT01677325
lead sponsor: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The CT ratio of liver/spleen
time frame: 12 weeks
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 .
measure: BMI(Body Mass Index )
time frame: 12 weeks
description: Body Mass Index,(weight/height^2)
measure: liver function
time frame: 12 weeks
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)
measure: lipid profile
time frame: 12 weeks
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)
measure: NEFA(nonesterified fatty acid)
time frame: 12 weeks
description: Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)
measure: HOMA index
time frame: 12 weeks
description: HOMA index(FBG*INSULIN/22.5)
measure: adiponectin
time frame: 12 weeks
description: adiponectin(pg/ml,Enzyme-linked immunosorbent assay)
measure: IL-6(interleukin 6)
time frame: 12 weeks
description: interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)
measure: hs-CRP (C-reactive protein)
time frame: 12 weeks
description: high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)
measure: TNFα( tumor necrosis factor-α)
time frame: 12 weeks
description: tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)
measure: leptin
time frame: 12 weeks
description: leptin(ng/ml,Enzyme-linked immunosorbent assay)
measure: renal function
time frame: 12 weeks
description: creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer)
measure: Routine blood
time frame: 12 weeks
description: automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:％.
measure: Routine urine examination
time frame: 12 weeks
description: automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-).
measure: Routine stool examination
time frame: 12 weeks
description: automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-)
measure: electrocardiography
time frame: 12 weeks
description: automatic electrocardiograph machine
measure: chest x-ray check
time frame: 12 weeks
description: diagnostic X-ray apparatus
arm group label: Chinese herb
arm group type: Experimental
description: Chinese herb
intervention type: Drug
intervention name: Chinese herb (YiQiSanJu)
description: Chinese herb formula:Huangqi,huanglian,yinchen,ect
arm group label: Chinese herb
other name: YiQiSanJu Formula
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Wen-Jian Wang, Ph.D,MD
role: Principal Investigator
affiliation: Huashan Hospital, affliated to Fudan University
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Wen-Jian Wang
investigator title: Professor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease