Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study
NCT ID: NCT03607383
Last Updated: 2019-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2018-02-07
2020-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* Indication to mild or moderate statin based on AHA 2013 guidelines
* Treatment naïve
Exclusion Criteria
* Renal or hepatic terminal disease
* Any contra indication to statin treatment
* Pregnancy wish during study period
* Familial hypercholesterolemia
18 Years
ALL
Yes
Sponsors
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Saint-Joseph University
OTHER
Responsible Party
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Principal Investigators
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Marouan Zoghbi
Role: PRINCIPAL_INVESTIGATOR
Hôtel Dieu de France Hospital
Locations
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Saint Anthony Primary Care Center
Jdeïdé, , Lebanon
Countries
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Central Contacts
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Facility Contacts
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Marouan Zoghbi, MD
Role: primary
Other Identifiers
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RRY2018
Identifier Type: -
Identifier Source: org_study_id
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