Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study

Conditions
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Dyslipidemias, LDL Hyperlipoproteinemia

Intervention / Treatment
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* Drug: Red Rice Yeast Extract
* Drug: Statin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Red rice yeast group<br>Red rice yeast based product will be provided under the brand name Molval Fort, one pill a day, for 8 weeks, for a moderate intensity treatment equivalent according the American College of Cardiology/American Heart Association (ACC/AHA) guidelines definitions | Drug: Red Rice Yeast Extract<br>* 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<br>|
| Active Comparator: Statin group<br>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 | Drug: Statin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL reduction | after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of side effects | after eight weeks of treatment, the incidence of side effects is studied among the red rice yeast group | eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statins, red rice yeast, adverse effects, cholesterol, LDL, treatment outcome, tolerability