Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000288628
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
5/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study on the Safety and Efficacy of Sylvan Red Yeast Rice in Adults with Primary Hypercholesterolemia
Scientific title
Study on the Safety and Efficacy of Sylvan Red Yeast Rice in Adults with Primary Hypercholesterolemia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 376 0
Condition category
Condition code
Diet and Nutrition 446 446 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active treatment was 2.4g Red Yeast Rice taken orally. The placebo was made up of the same excipient base as the active treatment and was indistinguishable in size, shape and taste to the active treatment and was taken orally.
Stage 1 (12 weeks)was a three arm study as follows: Arm 1: participants taking 2 active capsules with a meal in the morning and 2 active capsules with a meal at night.
Arm 2: participants taking 2 placebo capsules with a meal in the morning and 2 active capsules with a meal at night
Arm 3: participants taking 2 placebo capsules with a meal in the morning and 2 placebo capsules with a meal at night.
Stage 2: Particpants subsequently took 2 active tablets in the morning and two active tablets at night for 40 weeks. Stage3: Participants took 2 active capsules at night and 2 active capsules in the morning for 48 weeks.
Intervention code [1] 264 0
Treatment: Other
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 504 0
Change in LDL cholesterol from baseline to end of treatment.
Timepoint [1] 504 0
At baseline and at end of treatment
Secondary outcome [1] 1089 0
Change in total cholesterol
Timepoint [1] 1089 0
Baseline, week 4, week 8, week 12 and every 8 weeks till end of treatment.
Secondary outcome [2] 1090 0
Change in total high-density lipoprotein cholesterol (HDL)
Timepoint [2] 1090 0
Baseline, week 4, week 8, week 12 and every 8 weeks till end of treatment.
Secondary outcome [3] 1091 0
Change in total triglycerides.
Timepoint [3] 1091 0
Baseline, week 4, week 8, week 12 and every 8 weeks till end of treatment.

Eligibility
Key inclusion criteria
LDL cholesterol 3.5 - 5.7 mmol/L. Body mass index 32kg/m2.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Triglyceride levels > 4 mmol/L. Total cholesterol > 10 mmol/L. Use of lipid lowering medications including herbal and other natural lipid lowering agents within one month of baseline. Liver function enzymes >3 times the upper limit of normal at baseline. Pregnant women or women unwilling to use birth control for the duration of the study.Diabetes. Hypothyroidism. Smoking. Cardiovascular disease. Subjects unwilling to comply with study protocol. Poor venous access. Any other condition, which in the opinion of the investigators 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)
A third party who is independent of the study generated the randomised numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
MS Excel random number generator
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
7/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 496 0
Commercial sector/Industry
Name [1] 496 0
Sylvan Australia
Country [1] 496 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sylvan Australia Pty Ltd
Address
Sylvan Australia Pty Ltd
189 The Northern Rd
Londonderry NSW 2753
Country
Australia
Secondary sponsor category [1] 405 0
None
Name [1] 405 0
none
Address [1] 405 0
Country [1] 405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1472 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 1472 0
Ethics committee country [1] 1472 0
Australia
Date submitted for ethics approval [1] 1472 0
Approval date [1] 1472 0
Ethics approval number [1] 1472 0
Ethics committee name [2] 1473 0
University of Queensladn Human Research Ethics Committee
Ethics committee address [2] 1473 0
Ethics committee country [2] 1473 0
Australia
Date submitted for ethics approval [2] 1473 0
Approval date [2] 1473 0
Ethics approval number [2] 1473 0

Summary
Brief summary
This stage is a randomised, double blind, placebo-controlled, three arm parallel study. The study will compare baseline lipid levels with post-treatment levels for the treatment and placebo groups over a 12-week period. Interim analyses of the data will be conducted at the completion of stage 1, and subjects will be issued with the active medication at the end of week 12. The analysis of data will continue for 8 weeks. Stage 2 continued as an open label trial for 40 weeks and stage 3 continued as an open label trial for a further 48 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36393 0
Address 36393 0
Country 36393 0
Phone 36393 0
Fax 36393 0
Email 36393 0
Contact person for public queries
Name 9453 0
Professor Stephen Myers
Address 9453 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9453 0
Australia
Phone 9453 0
+61 2 66203403
Fax 9453 0
+61 2 66203307
Email 9453 0
smyers@scu.edu.au
Contact person for scientific queries
Name 381 0
Joan O'Connor
Address 381 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 381 0
Australia
Phone 381 0
+61 2 66203649
Fax 381 0
+61 2 66203307
Email 381 0
joconnor@scu.edu.au

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.