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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03607383
• Other study ID #: RRY2018
• Status: Recruiting
• Phase: Phase 2
• Start date: February 7, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: October 2019
• Source: Saint-Joseph University
• Contact: Marouan Zoghbi
• Phone: 9613552317
• Email: marouan.zoghbi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperlipidemias
• Hyperlipoproteinemias
• LDL Hyperlipoproteinemia

Intervention

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
• 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

Locations

Country	Name	City	State
Lebanon	Saint Anthony Primary Care Center	Jdeide

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	physician and patient satisfaction	physician and patient satisfaction will be evaluated by a single question questionnaire: Were you satisfied by the treatment?	eight weeks
Primary	LDL reduction	after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups	eight weeks
Secondary	incidence of side effects	after eight weeks of treatment, the incidence of side effects is studied among the red rice yeast group	eight weeks