NCT02548832

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

Completed Phase 3 Results posted Last updated 17 May 2022

What this trial tests

Phase 3 trial testing Berberine in Mixed Dyslipidemia in 36 participants. Completed in 1 April 2020.

Timeline

1 April 2013

Primary endpoint
1 April 2020

1 April 2020

Quick facts

Lead sponsor	University of Guadalajara
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	36
Start date	1 April 2013
Primary completion	1 April 2020
Estimated completion	1 April 2020
Sites	1 location across Mexico

Drugs / interventions tested

• Berberine — full drug profile →
• Bezafibrate (BEZAFIBRATE) — full drug profile →
• Berberine plus Bezafibrate — full drug profile →

Conditions studied

• Mixed Dyslipidemia — all drugs for Mixed Dyslipidemia →

Sponsor

University of Guadalajara

Who can join

Adults 30 to 60, any sex, with Mixed Dyslipidemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Triglycerides After 90 Days
  Time frame: 90 days
  The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
• Total Cholesterol After 90 Days.
  Time frame: 90 days
  The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
• Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
  Time frame: 90 days
  The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
• High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
  Time frame: 90 days
  The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
• Very Low Density Lipoprotein After 90 Days
  Time frame: 90 days
  The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.