NAFLD( Non-alcoholic Fatty Liver Disease )Phase 1NCT01677325
The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
A Phase 1 study testing Chinese herb (YiQiSanJu) in people with NAFLD( Non-alcoholic Fatty Liver Disease ), run by Fudan University.
Trial summary
To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- NAFLD( Non-alcoholic Fatty Liver Disease )
- What is being tested?
- Chinese herb (YiQiSanJu)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.
Read the detailed description
- 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.
- Being tested
- Chinese herb (YiQiSanJu)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herb (YiQiSanJu)Drug
Also called YiQiSanJu Formula
Chinese herb formula:Huangqi,huanglian,yinchen,ect
| Study group | Role | What they receive |
|---|---|---|
| Chinese herb | Experimental | Chinese herb Receives: Drug: Chinese herb (YiQiSanJu) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 12 weeks
Secondary outcomes (10)
BMI(Body Mass Index )
Body Mass Index,(weight/height^2)
Measured: 12 weeks
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)
Measured: 12 weeks
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)
Measured: 12 weeks
NEFA(nonesterified fatty acid)
Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)
Measured: 12 weeks
HOMA index
HOMA index(FBG*INSULIN/22.5)
Measured: 12 weeks
adiponectin
adiponectin(pg/ml,Enzyme-linked immunosorbent assay)
Measured: 12 weeks
IL-6(interleukin 6)
interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)
Measured: 12 weeks
hs-CRP (C-reactive protein)
high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)
Measured: 12 weeks
TNFα( tumor necrosis factor-α)
tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)
Measured: 12 weeks
leptin
leptin(ng/ml,Enzyme-linked immunosorbent assay)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startJan 2007
- Primary completionJan 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD( Non-alcoholic Fatty Liver Disease )Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Jian Wang, Fudan University
- Investigators
- Wen-Jian Wang, Ph.D,MD, Principal investigator, Huashan Hospital, affliated to Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677325
- Sponsor's protocol ID
- 2006-65
- Status last verified
- Sep 2012
- First submitted
- 28 Aug 2012
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT01677325
- Acronym / sponsor ID
- 2006-65
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese herb | Experimental | Drug: Chinese herb (YiQiSanJu)Chinese herb |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese herb (YiQiSanJu)Also: YiQiSanJu FormulaChinese herb formula:Huangqi,huanglian,yinchen,ect | Drug | Chinese herb |
Primary outcome
The CT ratio of liver/spleen
Time frame: 12 weeks
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 .
10 secondary outcomes
BMI(Body Mass Index )
Time frame: 12 weeks
liver function
Time frame: 12 weeks
lipid profile
Time frame: 12 weeks
NEFA(nonesterified fatty acid)
Time frame: 12 weeks
HOMA index
Time frame: 12 weeks
adiponectin
Time frame: 12 weeks
IL-6(interleukin 6)
Time frame: 12 weeks
hs-CRP (C-reactive protein)
Time frame: 12 weeks
TNFα( tumor necrosis factor-α)
Time frame: 12 weeks
leptin
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Jian Wang, Ph.D,MD principal investigator
Huashan Hospital, affliated to Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chinese herb (YiQiSanJu) in people with NAFLD( Non-alcoholic Fatty Liver Disease ), run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The CT ratio of liver/spleen (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.