Bezafibrate Plus Berberine in Mixed Dyslipidemia
Condition: Mixed Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The aim of this study is to evaluate the effect of berberine plus bezafibrate administration
      on the lipid profile of patients with mixed dyslipidemia.The investigators will conduct a
      double-blind randomized pilot clinical trial with parallel groups in men and women aged 30-60
      years old with diagnosis of mixed dyslipidemia.

      Patients will be assigned to 3 groups:

        1. 12 patients will receive berberine, 1500 mg / day

        2. 12 Patients will receive bezafibrate 400 mg / day

        3. 12 patients will receive a combination of berberine (1500 mg / day) plus bezafibrate
           (400 mg / day).

      All participants will be determined before and after the intervention: lipid profile, total
      cholesterol (TC), triglycerides (TG), HDL-C, low-density lipoprotein cholesterol (LDL-C),
      very low-density lipoprotein (VLDL).

      Also weight, Body Mass Index (BMI), waist circumference (WC), glucose, systolic blood
      pressure (SBP), diastolic blood pressure (DBP), creatinine (CR) uric acid (UA) and
      tolerability.

      Statistical analysis was performed upon the sample of subjects.

      Previous start the statistical analysis of the groups will proceed to verify the behavior of
      the distribution of the variables included by Z Kolmogorov-Smirnov goodness of fit.

      The distribution of all the variables under this test is cataloged in normal or not normal,
      which define the type of statistical test would be performed (parametric or non-parametric).
      However, based on the sample size, non-parametric tests will be those considered most
      suitable for application.

      The data obtained will be expressed and presented using measures of central tendency and
      dispersion for quantitative (mean and standard deviation) variables and qualitative variables
      are expressed as frequencies and percentages.
    

Intervention name(s): Berberine; Bezafibrate; Berberine plus Bezafibrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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 capsule 400 mg each 24 h for 90 days.
1 Bezafibrate capsule 200 mg for breakfast.
1 Bezafibrate capsule 200 mg for dinner.; 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.
Other intervention name(s): Berberine, bezafibrate
Intervention MeSH terms: Bezafibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Berberine; Bezafibrate