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The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

Phase 1
18 Years
65 Years
Not Enrolling
NAFLD( Non-alcoholic Fatty Liver Disease )

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Trial Information

The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

The CT ratio of liver/spleen

Outcome 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 .

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Wen-Jian Wang, Ph.D,MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huashan Hospital, affliated to Fudan University


China: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

January 2008

Related Keywords:

  • NAFLD( Non-alcoholic Fatty Liver Disease )
  • Fatty Liver
  • Liver Diseases