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

Saint-Joseph University

Status and phase: Unknown; Phase 2

Conditions: Dyslipidemias; LDL Hyperlipoproteinemia

Treatments: Drug: Red Rice Yeast Extract; Drug: Statin

Study type: Interventional

Funder types: Other

Identifiers

NCT03607383

RRY2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Red rice yeast group

Experimental group

Description:

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

Treatment:

Drug: Red Rice Yeast Extract

Statin group

Active Comparator group

Description:

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

Treatment:

Drug: Statin