Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/06/2005
Date assigned
21/09/2005
Last edited
14/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Myers

ORCID ID

Contact details

P.O. Box 157
Lismore
2480
Australia
+61 (0)2 66 20 3403
smyers@scu.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTN RR 141

Study information

Scientific title

Acronym

RYR

Study hypothesis

Treatment with Red Yeast Rice will significantly lower Low-Density Lipoprotein (LDL) levels.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hypercholesteremia

Intervention

Red Yeast Rice Stage One: 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 one, and subjects will be issued with the active medication at the end of week 12. The analysis of data will continue for eight weeks.
16 weeks - Four weeks wash out for subjects ceasing lipid-lowering agents. After determination of baseline lipid levels subjects will be assigned to 12 weeks of treatment.
Interim analysis of data eight weeks. Subjects will continue on active treatment.
Arm one: 24 participants taking two active capsules, with a meal in the morning and two placebo capsules with a meal at night
Arm two: 24 participants taking two active capsules with a meal in the morning and two active capsules with a meal at night
Arm three: 24 participants taking two placebo capsules with a meal in the morning and two placebo capsules with a meal at night

Stage Two: An open labelled study where all subjects receive the active treatment over 32 weeks. Participants taking two active capsules with a meal in the morning and two active capsules with a meal at night.

Intervention type

Drug

Phase

Not Specified

Drug names

Red Yeast Rice

Primary outcome measures

Change in LDL cholesterol from baseline to end of treatment.

Secondary outcome measures

Change in total cholesterol, High-Density Lipoprotein cholesterol (HDL) and triglycerides.

Overall trial start date

01/07/2005

Overall trial end date

30/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. LDL cholesterol more than or equal to 3.5 to less than or equal to 5.7 mmol/l
2. Aged 18 to 75 years
3. Body mass index less than or equal to 32 kg/m^2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

1. Triglyceride levels more than 4 mmol/l
2. Total cholesterol more than 10 mmol/l
3. Use of lipid lowering medications including herbal and other "natural" lipid lowering agents within one month of baseline
4. Liver function enzymes more than three times the upper limit of normal at baseline
5. Pregnant women or women unwilling to use birth control for the duration of the study
6. Diabetes
7. Hypothyroidism
8. Smoking
9. Cardiovascular disease
10. Subjects unwilling to comply with study protocol
11. Poor venous access
12. Any other condition, which in the opinion of the investigators could compromise the study

Recruitment start date

01/07/2005

Recruitment end date

30/07/2005

Locations

Countries of recruitment

Australia

Trial participating centre

P.O. Box 157
Lismore
2480
Australia

Sponsor information

Organisation

Sylvan Health Pty Ltd (Australia)

Sponsor details

189 The Northern Road
Londonderry NSW
2753
Australia

Sponsor type

Industry

Website

http://www.sylvaninc.com

Funders

Funder type

Industry

Funder name

Sylvan Health Pty Ltd (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes