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

Sponsor

Saint-Joseph University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03607383

Collaborator

(none)

Enrollment

Location

Arms

26.7

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias LDL Hyperlipoproteinemia	Drug: Red Rice Yeast Extract Drug: Statin	Phase 2

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

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 7, 2018

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Red 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
Active Comparator: 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	Drug: Statin 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

Arm

Intervention/Treatment

Experimental: 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

Drug: Red 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

Active Comparator: 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

Drug: Statin

Outcome Measures

Primary Outcome Measures

LDL reduction [eight weeks]
after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups

Secondary Outcome Measures

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 Outcome Measures

physician and patient satisfaction [eight weeks]
physician and patient satisfaction will be evaluated by a single question questionnaire: Were you satisfied by the treatment?