Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- LDL reduction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Red rice yeast group
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
Intervention: Red Rice Yeast Extract (Drug)
Statin group
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
Intervention: Statin (Drug)
Outcomes
Primary Outcomes
LDL reduction
Time Frame: eight weeks
after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups
Secondary Outcomes
- incidence of side effects(eight weeks)