Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2018
CompletedFirst Submitted
Initial submission to the registry
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedOctober 8, 2019
October 1, 2019
2.2 years
June 26, 2018
October 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL reduction
after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups
eight weeks
Secondary Outcomes (1)
incidence of side effects
eight weeks
Other Outcomes (1)
physician and patient satisfaction
eight weeks
Study Arms (2)
Red rice yeast group
EXPERIMENTALRed 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
Statin group
ACTIVE COMPARATORStatin 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
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 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
You may qualify if:
- Adult patient (\>18 years)
- Indication to mild or moderate statin based on AHA 2013 guidelines
- Treatment naïve
You may not qualify if:
- Allergy to rice
- Renal or hepatic terminal disease
- Any contra indication to statin treatment
- Pregnancy wish during study period
- Familial hypercholesterolemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Anthony Primary Care Center
Jdeïdé, Lebanon
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marouan Zoghbi
Hôtel Dieu de France Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2018
First Posted
July 31, 2018
Study Start
February 7, 2018
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
October 8, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share