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Trial registered on ANZCTR


Trial ID
ACTRN12605000257662
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
1/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Follow-up Study of the Efficacy of a Complementary Medicine Formulation in Primary Hypercholesterolemia
Scientific title
A Follow-up Study to determine the efficacy and safety profile of a Pathway formulation in lowering lipid levels in primary hypercholesteremia over a 24-week period. of a Complementary Medicine Formulation in Primary Hypercholesterolemia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary hypercholesteremia 344 0
Condition category
Condition code
Diet and Nutrition 397 397 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A novel combination of plant extracts and vitamins which was delivered over 24 weeks.
Intervention code [1] 261 0
Treatment: Other
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 458 0
Changes in fasting serum low-density lipoprotein (LDL) cholesterol level from baseline to end of treatment.
Timepoint [1] 458 0
Secondary outcome [1] 992 0
Changes in fasting serum levels of total cholesterol
Timepoint [1] 992 0
Secondary outcome [2] 993 0
Changes in high-density lipoprotein cholesterol (HDL)
Timepoint [2] 993 0
Secondary outcome [3] 994 0
Changes in triglycerides
Timepoint [3] 994 0
Secondary outcome [4] 995 0
Changes in apolipoproteins B and A-1
Timepoint [4] 995 0
Secondary outcome [5] 996 0
Changes in coenzyme Q10 and homocysteine.
Timepoint [5] 996 0

Eligibility
Key inclusion criteria
1. LDL cholesterol ³3.5 and 5.7mmol/L 2. 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
75 Years
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 study5. Individuals with diabetes6. Individuals with hyperthyroidism7. Individuals with obstructive bile duct disease8. Individuals with metabolic disorders other than primary hypercholesterolaemia, includingphytosterolaemia9. Individuals who smoke10. Individuals with cardiovascular disease11. Subjects unwilling to comply with the study protocols12. Subjects with poor venous access13. Any other condition which in the opinion of the researchers could compromise the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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] 449 0
Charities/Societies/Foundations
Name [1] 449 0
Pathways
Address [1] 449 0
Country [1] 449 0
Primary sponsor type
Charities/Societies/Foundations
Name
Pathways
Address
Country
Australia
Secondary sponsor category [1] 366 0
None
Name [1] 366 0
none
Address [1] 366 0
Country [1] 366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1423 0
Southern Cross university Human research Ethics Committee
Ethics committee address [1] 1423 0
Ethics committee country [1] 1423 0
Australia
Date submitted for ethics approval [1] 1423 0
Approval date [1] 1423 0
Ethics approval number [1] 1423 0

Summary
Brief summary
A follow-up study to determine the efficacy and safety profile of a natural medicine formulation in lowering lipid levels in primary hypercholesteremia over a 6-month period. The study also looked at the effect of the preparation on coenzyme Q10 levels.Study blood parameters were measured every 4 weeks
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35999 0
Address 35999 0
Country 35999 0
Phone 35999 0
Fax 35999 0
Email 35999 0
Contact person for public queries
Name 9450 0
Professor Stephen Myers
Address 9450 0
Australian Centre for Complementary Medicine Education and Research (ACCMER) PO Box 157
Lismore NSW 2480
Country 9450 0
Australia
Phone 9450 0
+61 2 66203403
Fax 9450 0
+61 2 66203307
Email 9450 0
smyers@scu.edu.au
Contact person for scientific queries
Name 378 0
Joan O'Connor
Address 378 0
Australian Centre for Complementary Medicine Education and Research (ACCMER) PO Box 157
Lismore NSW 2480
Country 378 0
Australia
Phone 378 0
+61 2 66203649
Fax 378 0
+61 2 66203307
Email 378 0
joconnor@scu.edu.au