CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
Berberine +2 moredrug
Likely dose
Berberine 1500 mgfrom 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/NCT02548832
NCT02548832Phase 3Completed

Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients With Mixed Dyslipidemia: A Pilot Clinical Trial

University of Guadalajara·interventional·Posted Sep 14, 2015·Updated Feb 24, 2023

In Brief

A Phase 3 clinical trial evaluating Berberine, Bezafibrate, and 1 other intervention for Mixed Dyslipidemia. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has increased over the last decade. Part of the components of metabolic syndrome and consensus so far contemplated to increased triglycerides (TG) and reduced high-density lipoprotein cholesterol (HDL-C) as part of the elements for classification, which includes mixed dyslipidemia. Currently, fibrates, such as bezafibrate, are drugs used in treating hypertriglyceridemia, besides reducing the risk of coronary disease. However, although this treatment is safe, it is not without risks; with increased prevalence of adverse effects as the dose thereof is increased or joins combination with a statin drug for the treatment of mixed dyslipidemia long term. Among the alternative therapies is berberine, which to reduce cholesterol and triglycerides may be useful in combination with bezafibrate in the treatment of mixed dyslipidemia and as an option with lower cost and lower frequency of adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2015
Enrollment StartApr 1, 2013
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 10.8 years ago

Interventions

Berberinedrug

Berberine 1500 mg, each 24 h for 90 days 1 Berberine capsule 500 mg for breakfast. 1 Berberine capsule 500 mg for lunch. 1 Berberine capsule 500 mg for dinner.

Bezafibratedrug

Bezafibrate capsule 400 mg each 24 h for 90 days. 1 Bezafibrate capsule 200 mg for breakfast. 1 Bezafibrate capsule 200 mg for dinner.

Berberine plus Bezafibratedrug

Berberine 1500 mg each 24 h for 90 days 1 Berberine capsule 500 mg for breakfast. 1 Berberine capsule 500 mg for lunch. 1 Berberine capsule 500 mg for dinner. Bezafibrate 400 mg each 24 h for 90 days. 1 Bezafibrate capsule 200 mg for breakfast. 1 Bezafibrate capsule 200 mg for dinner.