A Phase 4 interventional study of Berberine;Atorvastatin or Rosuvastatin and Atorvastatin or Rosuvastatin in Dyslipidemias, sponsored by Wenzhou Medical University. Terminated at 1 site in China. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-28.
Sponsored by Wenzhou Medical University · Phase 4 and Interventional
Statins are cholesterol-lowering medications that are often prescribed for patients with high cholesterol and who are at risk for cardiovascular disease (CVD). But there are many patients whose hyperlipemia are not well controlled. If investigators are simply doubling the statins, that only 6% of the benefit can be received. And it often has significant side effects in elder patients. Several studies have suggested that the use of berberine can effectively lower blood lipids. The chemical structure and mechanisms of drug is clearly, and the side effects are seldom, the price of berberine is very cheap. The purpose of this study is to observe the therapeutic effects of combination of statins and berberine on the patients with hyperlipemia whose level of the lipid are not well controlled when only using statins.
Patients at risk for cardiovascular disease (CVD) are often prescribed statins, which are medications that reduce the amount of cholesterol in the blood. By lowering cholesterol levels, these patients have a lower incidence of coronary artery disease, ischemic stroke, and peripheral arterial disease and so on. But there are many patients whose hyperlipemia are not well controlled.If investigators are simply doubling the statins, that only 6% of the benefit can be received.And it often bring significant side effects in elder patients. Several studies have suggested that the use of berberine can effectively lowering blood lipids.The chemical structure and mechanisms of drug is clearly, and the side effects are seldom, the price of berberine is very cheap. The purpose of this study is to observe the therapeutic effects of combination of statins and berberine on the patients with hyperlipemia whose level of the lipid are not well controlled when only using statins.
This study will enroll patients who currently take cholesterol-lowering medications，but the level of lipid is not controlled well. Patients will be assigned to receive 500mg of Berberine twice a day(meanwhile they are taking 20mg of Atorvastatin daily for 8 weeks or 10mg of Rosuvastatin daily for 8 weeks). Investigators will occur at baseline and Weeks 4 and 8. Blood will be collected for laboratory testing, and standardized psychological questionnaires will assess fatigue at baseline and weeks 4 and 8. Pill count will be used to assess adherence of Berberine and statins treatment at weeks 4 and 8. At weeks 4 and 8, medication side effects will be monitored and tests of alanine aminotransferase (ALT) and creatine phosphate kinase (CPK) will be performed. At weeks 4 and 8, medication efficacy will be assessed and test of low-density lipoprotein cholesterol (LDL-C) will be performed.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 24 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Wenzhou Medical University is the lead sponsor of 93 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Follow the previous administration program，participants will continue to receive 20mg Atorvastatin daily or 10mg Rosuvastatin daily; Besides taking statins, Participants will receive 500mg berberine twice a day for 8 weeks.
Drug: Berberine;Atorvastatin or Rosuvastatin
Due to the different clinical prescriptions by different doctors and similar Efficacy in lowering lipids.Usually,Participants receive 20mg Atorvastatin daily or 10mg Rosuvastatin to treat hyperlipidemia.
Drug: Atorvastatin or Rosuvastatin
Participants will receive 500mg Berberine twice a day for 8 weeks; Follow the previous administration program，participants will continue to receive 20mg Atorvastatin daily or 10mg Rosuvastatin daily.
Also known as: Berberine;, Liptor, Crestor
Due to the different clinical prescriptions by different doctors and similar Efficacy in lowering lipids.Usually,Participants receive 20mg Atorvastatin daily or 10mg Rosuvastatin to treat hyperlipidemia.
Also known as: Liptor, Crestor
Change from baseline in combination statins with berberine on lipid level
Time frame: Measured at baseline, weeks 4 and 8
Adherence of statins and berberine treatment
Time frame: Measured at weeks 4 and 8
This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Wenzhou Medical University