NAFLD( Non-alcoholic Fatty Liver Disease ) Clinical Trial
Official title:
The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
| Verified date | September 2012 |
| Source | Fudan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | January 2008 |
| Est. primary completion date | January 2007 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Fudan University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | renal function | creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer) | 12 weeks | Yes |
| Other | Routine blood | automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:%. | 12 weeks | Yes |
| Other | Routine urine examination | automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-). | 12 weeks | Yes |
| Other | Routine stool examination | automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-) | 12 weeks | Yes |
| Other | electrocardiography | automatic electrocardiograph machine | 12 weeks | Yes |
| Other | chest x-ray check | diagnostic X-ray apparatus | 12 weeks | Yes |
| Primary | The CT ratio of liver/spleen | 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 . | 12 weeks | No |
| Secondary | BMI(Body Mass Index ) | Body Mass Index,(weight/height^2) | 12 weeks | No |
| Secondary | liver function | Liver function enzymes- alanine aminotransferase (ALT,U/L), aspartate aminotransferase (AST,U/L) and ?-glutamyltransferase (GGT,U/L) and total bilirubin (TBI,µmol/L), albumin/globin (A/G)(Automatic biochemical analyzer) | 12 weeks | No |
| Secondary | lipid profile | 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) | 12 weeks | No |
| Secondary | NEFA(nonesterified fatty acid) | Insulin sensitivity of lipolysis using NEFA concentrations(µmol/L).(Enzyme-linked immunosorbent assay) | 12 weeks | No |
| Secondary | HOMA index | HOMA index(FBG*INSULIN/22.5) | 12 weeks | No |
| Secondary | adiponectin | adiponectin(pg/ml,Enzyme-linked immunosorbent assay) | 12 weeks | No |
| Secondary | IL-6(interleukin 6) | interleukin 6(pg/ml,Enzyme-linked immunosorbent assay) | 12 weeks | No |
| Secondary | hs-CRP (C-reactive protein) | high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay) | 12 weeks | No |
| Secondary | TNFa( tumor necrosis factor-a) | tumor necrosis factor-a(ng/L,Enzyme-linked immunosorbent assay) | 12 weeks | No |
| Secondary | leptin | leptin(ng/ml,Enzyme-linked immunosorbent assay) | 12 weeks | No |