Bezafibrate Plus Berberine in Mixed Dyslipidemia
Condition: Mixed Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Berberine; Bezafibrate; Berberine plus Bezafibrate
Intervention description: 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.
Intervention MeSH terms: Bezafibrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Someone of the team make a key number for each patient (36 enrolled, 12 for each intervention), and then put the numbers in to 36 paper envelopes and let the patient chose one. There was double-blind. And the placebo was calcined magnesia.
Enrollment: 36.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Berberine; Bezafibrate

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.
    

Eligibility criteria:

        Inclusion Criteria:

        A. Men and women

        B. Accomplished age 30 to 60 years

        C. Diagnosis of mixed dyslipidemia established to meet the following criteria:

          -  Total cholesterol > 5,17 mmol/l.

          -  Triglycerides > 1,7 mmol/l.

        D. BMI of 25 kg / m^2 to 39.9 kg / m^2, weight stable over the past three months, defined
        as a variability in the lower body weight of 5%.

        E. No drug treatment for lipid profile 3 months prior to baseline.

        F. Women must ensure a non-hormonal method to avoid pregnancy during the study period.

        G. Written information consent

        Exclusion Criteria:

        A. Removal for informed consent letter

        B. Loss of monitoring

        C. Presence of serious adverse event

        D. Adherence to treatment <80%

        E. Consumption of drugs known about lipid profile, glucose metabolism, blood pressure and
        body weight during the intervention period influence

        F. Intolerance or not tolerability or hypersensitivity to the compounds used in the study