The Therapeutic Effects of Statins and Berberine on the Hyperlipemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dyslipidemias |
Drug: Berberine;Atorvastatin or Rosuvastatin Drug: Atorvastatin or Rosuvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | The Therapeutic Effects of Combination of Statins With Berberine on the Patients With Hyperlipemia:a Single-center, Open Clinical Trial |
- Change from baseline in combination statins with berberine on lipid level [ Time Frame: Measured at baseline, weeks 4 and 8 ] [ Designated as safety issue: No ]
- Adherence of statins and berberine treatment [ Time Frame: Measured at weeks 4 and 8 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Berberine;Atorvastatin or Rosuvastatin
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
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.
Other Names:
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Active Comparator: 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
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.
Other Names:
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Current use of lipid-lowering medications;
- Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization [percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)] and other arterial revascularization procedures, ischaemic stroke, peripheral arterial disease(PAD);
- Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria); Patients with moderate to severe chronic kidney disease [glomerular filtration rate (GFR) < 60 mL/min/1.73㎡];
- Markedly elevated single risk factors such as familial dyslipidaemias and severe hypertension;
- A calculated SCORE ≥1% for 10 year risk of fatal CVD
Exclusion Criteria:
- Cancer;
- HIV infected;
- Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis);
- Active liver disease or unexplained persistent elevated transaminase levels；
- Major surgery or hospitalization in the 3 months prior to study entry;
- Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole" antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or protease inhibitors;
- Female of childbearing potential;
- Severe gastrointestinal disease;
- With berberine using contraindications;
- Secondary hyperlipidemia
- Current participation in another clinical trial
Contacts and Locations| China, Zhejiang | |
| Second Hospital of Wenzhou Medical College | Recruiting |
| Wenzhou, Zhejiang, China, 325000 | |
| Contact: JiFei Tang, Master +86 15968766021 497486104@qq.com | |
| Contact: Kangting Ji, Master +86 13676403180 heywyi@163.com | |
| Principal Investigator: | Jifei Tang, MD | Wenzhou Medical College |
More Information
No publications provided
| Responsible Party: | JiFei Tang, Director, Wenzhou Medical College |
| ClinicalTrials.gov Identifier: | NCT01697735 History of Changes |
| Other Study ID Numbers: | WZ medical college |
| Study First Received: | September 28, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | China: Ethics Committee |
Additional relevant MeSH terms:
|
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013