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Completed

NCT Number: NCT01677325

The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

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

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Key information

Conditions

NAFLD( Non-alcoholic Fatty Liver Disease )

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chinese herb (YiQiSanJu)

Drug

Chinese herb formula:Huangqi,huanglian,yinchen,ect

Other names: YiQiSanJu Formula

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Sep 3, 2012
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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