CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 26 enrolled
Drug / intervention
Nutraceutical combination (NC) +1 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/NCT03470376
NCT03470376Phase 4Completed
CompareCT.gov

Lipid-lowering and Vascular Effects of a Nutraceutical Combination in HIV-infected Patients on Stable Antiretroviral Therapy

University Of Perugia·interventional·Posted Mar 19, 2018·Updated Mar 23, 2018

In Brief

A Phase 4 clinical trial evaluating Nutraceutical combination (NC) and No nutraceutical combination (noNC) for Hypercholesterolemia and 2 related conditions. Completed, enrolled 26 participants.

Detailed Summary

The effects of a nutraceutical combination (NC) containing low-dose monacolin K and berberine on lipid profile, proprotein convertase subtilisin/kexin type 9 (PCSK9), subclinical inflammation and arterial stiffness were investigated in human immunodeficiency virus (HIV)-infected patients receiving stable antiretroviral therapy (ART).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Inflammation, Atherosclerosis
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 19, 2018
Enrollment StartJan 15, 2017
Primary CompletionNov 15, 2017
Study CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.3 years ago

Interventions

Nutraceutical combination (NC)dietary

An oral NC (red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg) one pill/day was administered for 3 months along with prosecution of standardized diet regimen

No nutraceutical combination (noNC)behavioral

Prosecution of standardized diet regimen for 3 months