MedTrace Logo

Long Term Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols and Berberine) in Low-moderate Risk Hypercholesterolemic Patients: a Double-blind, Placebo Controlled Study

NCT02078167 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-05

No results posted yet for this study

Summary

Background: Statins are at the forefront of strategies to manage hypercholesterolemia. However, 10-15% of patients result to be intolerant to any statins, even at low daily doses and almost one- third of statin users discontinue therapy within one year. Some nutraceuticals are prescribed as lipid- lowering substances, but doubts remain about their efficacy and tolerability. In this study we investigated the effects of a nutraceutical combination consisting mainly of red yeast rice extract 200 mg (equivalent to 3 mg monacolins), berberine 500 mg and policosanols 10 mg (MBP-NC).

Methods: In this single centre, randomized, double-blind, placebo-controlled study 60 consecutive outpatients (age range: 18-60 years), with newly diagnosed primary hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable hypolipidic diet, were randomized to receive a pill of MBP-NC (N=30) or placebo (N=30) once a day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability of the proposed nutraceutical treatment were fully assessed after 4, 12 and 24 weeks of treatment.

Conditions

Interventions

OTHER

nutraceutical combination (red yeast rice, policosanols and berberine)

Sponsors & Collaborators

  • Carla Caffarelli

    collaborator UNKNOWN

  • Comitato Etico di Area Vasta Sud Est

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-01-31
Completion
2013-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02078167 on ClinicalTrials.gov