Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03607383
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Saint-Joseph University

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 7, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. LDL reduction [ Time Frame: eight weeks ]
    after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups


Secondary Outcome Measures :
  1. incidence of side effects [ Time Frame: eight weeks ]
    after eight weeks of treatment, the incidence of side effects is studied among the red rice yeast group


Other Outcome Measures:
  1. physician and patient satisfaction [ Time Frame: eight weeks ]
    physician and patient satisfaction will be evaluated by a single question questionnaire: Were you satisfied by the treatment?



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607383


Contacts
Layout table for location contacts
Contact: Marouan Zoghbi 9613552317 marouan.zoghbi@gmail.com
Contact: Ralph Mezher 96171425999 ralph.mezher.RM@gmail.com

Locations
Layout table for location information
Lebanon
Saint Anthony Primary Care Center Recruiting
Jdeide, Lebanon
Contact: Marouan Zoghbi, MD    +9613552317      
Sponsors and Collaborators
Saint-Joseph University
Investigators
Layout table for investigator information
Principal Investigator: Marouan Zoghbi Hôtel Dieu de France Hospital

Layout table for additonal information
Responsible Party: Saint-Joseph University
ClinicalTrials.gov Identifier: NCT03607383     History of Changes
Other Study ID Numbers: RRY2018
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saint-Joseph University:
statins
red rice yeast
adverse effects
cholesterol, LDL
treatment outcome
tolerability
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyslipidemias
Hyperlipoproteinemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Red yeast rice
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents