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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
  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: 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:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 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:
  • BMI(Body Mass Index ) [ Time Frame: 12 weeks ]
    Body Mass Index,(weight/height^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)

  • 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)

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

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

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

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

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

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

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


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

  • 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:%.

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

  • 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(+-)

  • electrocardiography [ Time Frame: 12 weeks ]
    automatic electrocardiograph machine

  • chest x-ray check [ Time Frame: 12 weeks ]
    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   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on February 17, 2017