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 |
| Secondary identifying numbers | CTN RR 141 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | RYR |
| Study hypothesis | Treatment with Red Yeast Rice will significantly lower Low-Density Lipoprotein (LDL) levels. |
| Ethics approval(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Red Yeast Rice |
| Primary outcome measure | 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 study start date | 01/07/2005 |
| Overall study end date | 30/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 72 |
| 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 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
Study participating centre
P.O. Box 157
Lismore
2480
Australia
2480
Australia
Sponsor information
Sylvan Health Pty Ltd (Australia)
Industry
Industry
189 The Northern Road
Londonderry NSW
2753
Australia
| Website | http://www.sylvaninc.com |
|---|
Funders
Funder type
Industry
Sylvan Health Pty Ltd (Australia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
