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: Endpoint Classification: Efficacy Study
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 ] [ 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 .


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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


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
Genders 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
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

No publications provided

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
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014