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Trial registered on ANZCTR


Trial ID
ACTRN12605000232639
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
26/08/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dose Response Study of a Complementary Medicine Formulation in Primary Hypercholesterolaemia
Scientific title
Dose Response Studyto determine the efficacy and safety of a Complementary Medicine Formulation, in tablet form, for lowering lipid levels in primary Hypercholesterolaemia by comparing baseline levels of lipids with post treatment lipid levels.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Hypercholesterolaemia 318 0
Condition category
Condition code
Diet and Nutrition 363 363 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cynara scolymus:
One arm took one tablet of the study medication twice a day (morning and evening with meals) and the other arm took two tablets twice a day (morning and evening with meals).
Intervention code [1] 245 0
Treatment: Other
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 423 0
Changes in fasting serum low-density lipoprotein (LDL) cholesterol level from baseline to end of treatment.
Timepoint [1] 423 0
Secondary outcome [1] 910 0
Changes in fasting serum levels of total cholesterol.
Timepoint [1] 910 0
Secondary outcome [2] 911 0
Changes in high-density lipoprotein cholesterol (HDL).
Timepoint [2] 911 0
Secondary outcome [3] 912 0
Changes in triglycerides.
Timepoint [3] 912 0
Secondary outcome [4] 913 0
Changes in apolipoproteins B and A-1.
Timepoint [4] 913 0
Secondary outcome [5] 914 0
Coenzyme Q10 and homocysteine.
Timepoint [5] 914 0

Eligibility
Key inclusion criteria
LDL cholesterol 3.5 and 5.7mmol/L2. Body mass index 32kg/m23. Subject is willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals with triglyceride levels >4mmol/L2. Individuals with a total cholesterol level >10 mmol/L3. Individuals with clinically abnormal liver function tests at baseline (measured at visit 2). 4. Women who are pregnant or unwilling to use birth control for the period of the study. 5.Individuals with diabetes6. Individuals with hyperthyroidism. 7.Individuals with obstructive bile duct disease. 8.Individuals with metabolic disorders other than primary hypercholesterolaemia, including phytosterolaemia. 9.Individuals who smoke. 10.Individuals with cardiovascular disease. 11.Subjects unwilling to comply with the study protocols. 12.Subjects with poor venous access. 13.Any other condition which in the opinion of the researchers could compromise the study.

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)
Participants were assigned by a first come first recruited basis. The tablets were supplied in numbered containers by the sponsors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were assigned to the treatment groups by coin toss after initial recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 422 0
Charities/Societies/Foundations
Name [1] 422 0
Pathways
Address [1] 422 0
Country [1] 422 0
Primary sponsor type
Charities/Societies/Foundations
Name
Pathways
Address
Country
Australia
Secondary sponsor category [1] 341 0
None
Name [1] 341 0
none
Address [1] 341 0
Country [1] 341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1394 0
Southern Cross University HUman Researh Ethics Committee
Ethics committee address [1] 1394 0
Ethics committee country [1] 1394 0
Australia
Date submitted for ethics approval [1] 1394 0
Approval date [1] 1394 0
Ethics approval number [1] 1394 0

Summary
Brief summary
This study is a two arm open comparison of two different dosage regimes undertaken in a homogeneous population comparing baseline measurements with effects of treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35723 0
Address 35723 0
Country 35723 0
Phone 35723 0
Fax 35723 0
Email 35723 0
Contact person for public queries
Name 9434 0
Professor Stephen Myers
Address 9434 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9434 0
Australia
Phone 9434 0
+61 2 66203403
Fax 9434 0
+61 2 66203307
Email 9434 0
smyers@scu.edu.au
Contact person for scientific queries
Name 362 0
Joan O'Connor
Address 362 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 362 0
Australia
Phone 362 0
+61 2 66203649
Fax 362 0
+61 2 66203307
Email 362 0
joconnor@scu.edu.au