Dyslipidemias, LDL Hyperlipoproteinemia
Conditions
Keywords
statins, red rice yeast, adverse effects, cholesterol, LDL, treatment outcome, tolerability
Brief summary
Red yeast rice is a source of active compounds in reducing LDL levels with practically no side effects. Molval Fort is a natural product available in the Lebanese market with a combination of red yeast rice extracts, EPA/DHA and coenzyme Q10. The investigators are conducting this study to explore the effect of red yest rice extracts based product on LDL and its side effects in a sample of primary care Lebanese patients.
Detailed description
Red yeast rice is a source of active compounds in reducing LDL levels with practically no side effects. Studies performed on American and Chinese populations have shown positive results. These studies need confirmation in different populations. Molval Fort is a natural product available in the Lebanese market with a combination of red yeast rice extracts, EPA/DHA and coenzyme Q10. The investigators are conducting this study to explore the effect of red yest rice extracts based product on LDL and its side effects in a sample of primary care Lebanese patients.
Interventions
DRUGRed Rice Yeast Extract
adults requiring moderate intensity treatment will be provided red rice yeast extracts or statins, depending on the randomization; followed for compliance and adverse effects check, and reevaluated in a final visit with blood test after 8 weeks
DRUGStatin
Statin choice is done at the discretion of the treating physician for a moderate intensity treatment equivalent according the American College of Cardiology/American Heart Association (ACC/AHA) guidelines definitions, for 8 weeks
Sponsors
Saint-Joseph University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patient (\>18 years) * Indication to mild or moderate statin based on AHA 2013 guidelines * Treatment naïve
Exclusion criteria
* Allergy to rice * Renal or hepatic terminal disease * Any contra indication to statin treatment * Pregnancy wish during study period * Familial hypercholesterolemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL reduction | eight weeks | after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of side effects | eight weeks | after eight weeks of treatment, the incidence of side effects is studied among the red rice yeast group |
Other
| Measure | Time frame | Description |
|---|---|---|
| physician and patient satisfaction | eight weeks | physician and patient satisfaction will be evaluated by a single question questionnaire: Were you satisfied by the treatment? |
Countries
Lebanon
Contacts
Primary ContactMarouan Zoghbi
Backup ContactRalph Mezher
Outcome results
None listed