CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Nutraceutical Combination +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02422927
NCT02422927Phase 4Completed
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Effect of a Nutraceutical Combination on Endothelial Injury and C-reactive Protein in Patients With Low-grade Systemic Inflammation

University Of Perugia·interventional·Posted Apr 22, 2015·Updated Apr 22, 2015

In Brief

A Phase 4 clinical trial evaluating Nutraceutical Combination, Standard of Care, and 1 other intervention for Atherosclerosis and 2 related conditions. Completed, enrolled 100 participants.

Detailed Summary

The investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis, Inflammation, Hypercholesterolemia
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 22, 2015
Enrollment StartJul 1, 2014
Primary CompletionJan 1, 2015
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.2 years ago

Interventions

Nutraceutical Combinationdietary

red yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, berberine 500 mg, 0.2 mg folic acid, coenzyme Q10 2 mg, and astaxanthin 0.5 mg once daily

Standard of Careother

low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule

Placeboother

placebo