The Therapeutic Effects of Statins and Berberine on the Hyperlipemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Wenzhou Medical University
Sponsor:
Information provided by (Responsible Party):
JiFei Tang, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01697735
First received: September 28, 2012
Last updated: December 29, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: June 2015
Estimated Primary Completion Date: June 2015 (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:
  • Berberine;
  • Liptor
  • Crestor
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:
  • Liptor
  • Crestor

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
Criteria

Inclusion Criteria:

  1. Current use of lipid-lowering medications;
  2. 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);
  3. 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㎡];
  4. Markedly elevated single risk factors such as familial dyslipidaemias and severe hypertension;
  5. A calculated SCORE ≥1% for 10 year risk of fatal CVD

Exclusion Criteria:

  1. Cancer;
  2. HIV infected;
  3. Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis);
  4. Active liver disease or unexplained persistent elevated transaminase levels;
  5. Major surgery or hospitalization in the 3 months prior to study entry;
  6. Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole" antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or protease inhibitors;
  7. Female of childbearing potential;
  8. Severe gastrointestinal disease;
  9. With berberine using contraindications;
  10. Secondary hyperlipidemia
  11. Current participation in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697735

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   
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: Jifei Tang, MD Wenzhou Medical University
  More Information

No publications provided

Responsible Party: JiFei Tang, Director, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01697735     History of Changes
Other Study ID Numbers: WZ medical college
Study First Received: September 28, 2012
Last Updated: December 29, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014