NCT01677325

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

Same day

First QC Date

August 28, 2012

Last Update Submit

September 4, 2012

Conditions

NAFLD( Non-alcoholic Fatty Liver Disease )

Outcome Measures

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 .

    12 weeks

Secondary Outcomes (10)

  • BMI(Body Mass Index )

    12 weeks

  • liver function

    12 weeks

  • lipid profile

    12 weeks

  • NEFA(nonesterified fatty acid)

    12 weeks

  • HOMA index

    12 weeks

  • +5 more secondary outcomes

Other Outcomes (6)

  • renal function

    12 weeks

  • Routine blood

    12 weeks

  • Routine urine examination

    12 weeks

  • +3 more other outcomes

Study Arms (1)

Chinese herb

EXPERIMENTAL

Chinese herb

Drug: Chinese herb (YiQiSanJu)

Interventions

Chinese herb (YiQiSanJu)DRUG

Chinese herb formula:Huangqi,huanglian,yinchen,ect

Also known as: YiQiSanJu Formula
Chinese herb

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Wen-Jian Wang, Ph.D,MD

    Huashan Hospital, affliated to Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 28, 2012

First Posted

September 3, 2012

Study Start

January 1, 2007

Primary Completion

January 1, 2007

Study Completion

January 1, 2008

Last Updated

September 5, 2012

Record last verified: 2012-09