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CompletedNCT01677325Updated Sep 5, 2012

The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

A Phase 1 interventional study of Chinese herb (YiQiSanJu) in NAFLD( Non-alcoholic Fatty Liver Disease ), sponsored by Fudan University. Completed. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-09-05.

Sponsored by Fudan University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

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

Read the 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.
02

Conditions studied

  • NAFLD( Non-alcoholic Fatty Liver Disease )
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Chinese herb

    Chinese herb

    Drug: Chinese herb (YiQiSanJu)

Interventions

  • DrugChinese herb (YiQiSanJu)

    Chinese herb formula:Huangqi,huanglian,yinchen,ect

    Also known as: YiQiSanJu Formula

06

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: 12 weeks

Secondary outcomes

  1. BMI(Body Mass Index )

    Body Mass Index,(weight/height\^2)

    Time frame: 12 weeks

  2. liver function

    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)

    Time frame: 12 weeks

  3. 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)

    Time frame: 12 weeks

  4. NEFA(nonesterified fatty acid)

    Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)

    Time frame: 12 weeks

  5. HOMA index

    HOMA index(FBG\*INSULIN/22.5)

    Time frame: 12 weeks

  6. adiponectin

    adiponectin(pg/ml,Enzyme-linked immunosorbent assay)

    Time frame: 12 weeks

  7. IL-6(interleukin 6)

    interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)

    Time frame: 12 weeks

  8. hs-CRP (C-reactive protein)

    high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)

    Time frame: 12 weeks

  9. TNFα( tumor necrosis factor-α)

    tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)

    Time frame: 12 weeks

  10. leptin

    leptin(ng/ml,Enzyme-linked immunosorbent assay)

    Time frame: 12 weeks

Other outcomes

  1. renal function

    creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer)

    Time frame: 12 weeks

  2. Routine blood

    automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:％.

    Time frame: 12 weeks

  3. Routine urine examination

    automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-).

    Time frame: 12 weeks

  4. Routine stool examination

    automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-)

    Time frame: 12 weeks

  5. electrocardiography

    automatic electrocardiograph machine

    Time frame: 12 weeks

  6. chest x-ray check

    diagnostic X-ray apparatus

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01677325
Lead sponsor
Fudan University
Responsible party
Wen-Jian Wang (Professor, Fudan University) — Principal investigator
First posted
Sep 3, 2012
Start date
Jan 2007
Primary completion
Jan 2007
Completion
Jan 2008
Last update
Sep 5, 2012

Study contacts

Wen-Jian Wang, Ph.D,MD
principal investigator · Huashan Hospital, affliated to Fudan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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