The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

Fudan University

Status and phase: Completed; Phase 1

Conditions: NAFLD( Non-alcoholic Fatty Liver Disease )

Treatments: Drug: Chinese herb (YiQiSanJu)

Study type: Interventional

Funder types: Other

Identifiers

NCT01677325

2006-65

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 1 patient group

Chinese herb

Experimental group

Description:

Chinese herb

Treatment:

Drug: Chinese herb (YiQiSanJu)