Mixed Dyslipidemia Clinical Trial
Official title:
Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients With Mixed Dyslipidemia: A Pilot Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04998201 -
Study of ARO-APOC3 in Adults With Mixed Dyslipidemia
|
Phase 2 | |
| Not yet recruiting |
NCT03648788 -
A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe
|
||
| Completed |
NCT00300430 -
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
|
Phase 3 | |
| Recruiting |
NCT05399992 -
Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD
|
||
| Withdrawn |
NCT05798390 -
Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
|
||
| Completed |
NCT01256476 -
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
|
Phase 4 | |
| Completed |
NCT00171236 -
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
|
Phase 3 | |
| Completed |
NCT00487591 -
An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia
|
Phase 4 | |
| Terminated |
NCT03433755 -
Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia
|
Phase 3 | |
| Completed |
NCT02739984 -
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
|
Phase 3 | |
| Not yet recruiting |
NCT06386419 -
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
|
Phase 4 | |
| Terminated |
NCT01335997 -
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
|
Phase 3 | |
| Completed |
NCT00300456 -
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
|
Phase 3 | |
| Completed |
NCT00300482 -
Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood
|
Phase 3 | |
| Completed |
NCT00300469 -
Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
|
Phase 3 | |
| Recruiting |
NCT06314919 -
A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib
|
||
| Terminated |
NCT01274559 -
Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)
|
Phase 3 | |
| Active, not recruiting |
NCT04832971 -
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
|
Phase 2 | |
| Completed |
NCT00491530 -
A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
|
Phase 3 | |
| Completed |
NCT00136799 -
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
|
Phase 3 |