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The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine

NCT ID: NCT01677325

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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NAFLD( Non-alcoholic Fatty Liver Disease )

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Chinese herb

Chinese herb

Group Type EXPERIMENTAL

Chinese herb (YiQiSanJu)

Intervention Type DRUG

Chinese herb formula:Huangqi,huanglian,yinchen,ect

Interventions

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Chinese herb (YiQiSanJu)

Chinese herb formula:Huangqi,huanglian,yinchen,ect

Intervention Type DRUG

Other Intervention Names

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YiQiSanJu Formula

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Wen-Jian Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wen-Jian Wang, Ph.D,MD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital, affliated to Fudan University

Other Identifiers

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2006-65

Identifier Type: -

Identifier Source: org_study_id