Study on the safety and efficacy of sylvan Red Yeast Rice in adults with primary hypercholesteremia
| ISRCTN | ISRCTN74551315 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74551315 |
| Protocol serial number | CTN RR 141 |
| Sponsor | Sylvan Health Pty Ltd (Australia) |
| Funder | Sylvan Health Pty Ltd (Australia) |
- Submission date
- 02/06/2005
- Registration date
- 21/09/2005
- Last edited
- 14/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stephen Myers
Scientific
Scientific
P.O. Box 157
Lismore
2480
Australia
| Phone | +61 (0)2 66 20 3403 |
|---|---|
| smyers@scu.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | RYR |
| Study objectives | Treatment with Red Yeast Rice will significantly lower Low-Density Lipoprotein (LDL) levels. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Red Yeast Rice |
| Primary outcome measure(s) |
Change in LDL cholesterol from baseline to end of treatment. |
| Key secondary outcome measure(s) |
Change in total cholesterol, High-Density Lipoprotein cholesterol (HDL) and triglycerides. |
| Completion date | 30/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 72 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 30/07/2005 |
Locations
Countries of recruitment
- Australia
Study participating centre
P.O. Box 157
Lismore
2480
Australia
2480
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
