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Trial registered on ANZCTR


Registration number
ACTRN12612001288819
Ethics application status
Approved
Date submitted
3/12/2012
Date registered
12/12/2012
Date last updated
18/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized, double-blind pilot study of Yin-Chen-Hao-Tang in treating obese people with fatty liver
Scientific title
For obese people with fatty liver, dose Yin-Chen-Hao-Tang has effect on fatty liver degree?
Secondary ID [1] 281621 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The use of Yin-Chen-Hao-Tang herbal remedy in treating obese people with fatty liver 287899 0
Condition category
Condition code
Oral and Gastrointestinal 288279 288279 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 288322 288322 0 0
Herbal remedies
Diet and Nutrition 288323 288323 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Yin-Chen-Hao-Tang is a traditional Chinese herbal remedy composed of Artemisia capillaris (Yin Chen), Gardenia jasminoides Ellis (Zhi Zi) and Rheum officinale Baill (Da Huang). Patients were treated with Yin-Chen-Hao-Tang (extract granule; 0.375 gm/capsule; oral use), 4 capsules per time and 3 times per day , the treating course is 8 weeks.
Intervention code [1] 286153 0
Treatment: Other
Comparator / control treatment
placebo capsule (1/100 amount of Yin-Chen-Hao-Tang capsule) is used with the same regimen in controlled group.
Control group
Placebo

Outcomes
Primary outcome [1] 288454 0
fatty liver degree, as assessed by ultrasonographic stages
Timepoint [1] 288454 0
baseline and the 8th week
Secondary outcome [1] 300195 0
blood test for liver function and blood lipid level, including Aspartate transaminase (AST), Alanine aminotransferase (ALT), Gamma-glutamyl transpeptidase (gamma-GT) and triglyceride (TG)
Timepoint [1] 300195 0
baseline and the 8th week

Eligibility
Key inclusion criteria
participant who is obese with fatty liver that is diagnosed at outpatient department
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patient has ALT and AST levels of over 1000 u/L
2.Patient has a-Fetoprotein (AFP) levels of over 2 upper laboratory norms.
3.Patient is pregnant
4.Patients with alcoholic or drug abuse
5.Patients treatment with drugs, e.g. corticosteroids, high-dose estrogens, methotrexate, amiodarone, calcium channel blockers, spironolactone, sulfasalazine, naproxen, or oxacillin.
6.Patient has total cholesterol (TC) and triglyceride (TG) over 300 u/L
7.Patient has fast plasma glucose over 126 mg/dl, and postprandial plasma glucose over 200mg/dl
8.Patient has HBsAg positive
9.Patient has Anti-HCV positive
10.Patient with a malignancy which can influence prognosis
11.Patient has BP less than 90/50 mm/Hg

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
11/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4698 0
Taiwan, Province Of China
State/province [1] 4698 0

Funding & Sponsors
Funding source category [1] 286427 0
Hospital
Name [1] 286427 0
Taoyuan Chang Gung Memorial Hospital of The Chang Gung Medical Fundation
Country [1] 286427 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Taoyuan Chang Gung Memorial Hospital of The Chang Gung Medical Fundation
Address
NO.123, DINGHU RD., GUISHAN TOWNSHIP, TAOYUAN COUNTY 333, TAIWAN, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 285240 0
None
Name [1] 285240 0
Address [1] 285240 0
Country [1] 285240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288506 0
Chang Gung Medical Foundation Institutional Review Board
Ethics committee address [1] 288506 0
Ethics committee country [1] 288506 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 288506 0
01/03/2011
Approval date [1] 288506 0
01/04/2011
Ethics approval number [1] 288506 0
99-3538A3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35009 0
Dr Hen-Hong Chang
Address 35009 0
NO.123, Dinghu Rd., Guishan Township, Taoyuan County 333, Taiwan, R.O.C.
Country 35009 0
Taiwan, Province Of China
Phone 35009 0
+886-3-3196200#2676
Fax 35009 0
+886-3-3294841
Email 35009 0
tcmchh@mail.cgu.edu.tw
Contact person for public queries
Name 18256 0
Tzung-Yan Lee
Address 18256 0
No.259, Wenhwa 1st Rd, Guishan Township, Taoyuan County 333, Taiwan, R.O.C.
Country 18256 0
Taiwan, Province Of China
Phone 18256 0
+886-3-2118800#3537
Fax 18256 0
+886-3-3294841
Email 18256 0
joyamen@mail.cgu.edu.tw
Contact person for scientific queries
Name 9184 0
Tzung-Yan Lee
Address 9184 0
No.259, Wenhwa 1st Rd, Guishan Township, Taoyuan County 333, Taiwan, R.O.C.
Country 9184 0
Taiwan, Province Of China
Phone 9184 0
+886-3-2118800#3537
Fax 9184 0
+886-3-2118349
Email 9184 0
joyamen@mail.cgu.edu.tw

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.