<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01697735</url>
  </required_header>
  <id_info>
    <org_study_id>WZ medical college</org_study_id>
    <nct_id>NCT01697735</nct_id>
  </id_info>
  <brief_title>The Therapeutic Effects of Statins and Berberine on the Hyperlipemia</brief_title>
  <official_title>The Therapeutic Effects of Combination of Statins With Berberine on the Patients With Hyperlipemia:a Single-center, Open Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Statins are cholesterol-lowering medications that are often prescribed for patients with high&#xD;
      cholesterol and who are at risk for cardiovascular disease (CVD). But there are many patients&#xD;
      whose hyperlipemia are not well controlled. If investigators are simply doubling the statins,&#xD;
      that only 6% of the benefit can be received. And it often has significant side effects in&#xD;
      elder patients. Several studies have suggested that the use of berberine can effectively&#xD;
      lower blood lipids. The chemical structure and mechanisms of drug is clearly, and the side&#xD;
      effects are seldom, the price of berberine is very cheap. The purpose of this study is to&#xD;
      observe the therapeutic effects of combination of statins and berberine on the patients with&#xD;
      hyperlipemia whose level of the lipid are not well controlled when only using statins.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients at risk for cardiovascular disease (CVD) are often prescribed statins, which are&#xD;
      medications that reduce the amount of cholesterol in the blood. By lowering cholesterol&#xD;
      levels, these patients have a lower incidence of coronary artery disease, ischemic stroke,&#xD;
      and peripheral arterial disease and so on. But there are many patients whose hyperlipemia are&#xD;
      not well controlled.If investigators are simply doubling the statins, that only 6% of the&#xD;
      benefit can be received.And it often bring significant side effects in elder patients.&#xD;
      Several studies have suggested that the use of berberine can effectively lowering blood&#xD;
      lipids.The chemical structure and mechanisms of drug is clearly, and the side effects are&#xD;
      seldom, the price of berberine is very cheap. The purpose of this study is to observe the&#xD;
      therapeutic effects of combination of statins and berberine on the patients with hyperlipemia&#xD;
      whose level of the lipid are not well controlled when only using statins.&#xD;
&#xD;
      This study will enroll patients who currently take cholesterol-lowering medications，but the&#xD;
      level of lipid is not controlled well. Patients will be assigned to receive 500mg of&#xD;
      Berberine twice a day(meanwhile they are taking 20mg of Atorvastatin daily for 8 weeks or&#xD;
      10mg of Rosuvastatin daily for 8 weeks). Investigators will occur at baseline and Weeks 4 and&#xD;
      8. Blood will be collected for laboratory testing, and standardized psychological&#xD;
      questionnaires will assess fatigue at baseline and weeks 4 and 8. Pill count will be used to&#xD;
      assess adherence of Berberine and statins treatment at weeks 4 and 8. At weeks 4 and 8,&#xD;
      medication side effects will be monitored and tests of alanine aminotransferase (ALT) and&#xD;
      creatine phosphate kinase (CPK) will be performed. At weeks 4 and 8, medication efficacy will&#xD;
      be assessed and test of low-density lipoprotein cholesterol (LDL-C) will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Because of lack of participants and funds&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in combination statins with berberine on lipid level</measure>
    <time_frame>Measured at baseline, weeks 4 and 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence of statins and berberine treatment</measure>
    <time_frame>Measured at weeks 4 and 8</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Berberine;Atorvastatin or Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin or Rosuvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Berberine;Atorvastatin or Rosuvastatin</intervention_name>
    <description>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.</description>
    <arm_group_label>Berberine;Atorvastatin or Rosuvastatin</arm_group_label>
    <other_name>Berberine;</other_name>
    <other_name>Liptor</other_name>
    <other_name>Crestor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin or Rosuvastatin</intervention_name>
    <description>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.</description>
    <arm_group_label>Atorvastatin or Rosuvastatin</arm_group_label>
    <other_name>Liptor</other_name>
    <other_name>Crestor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Current use of lipid-lowering medications;&#xD;
&#xD;
          2. Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as&#xD;
             coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on&#xD;
             ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS),&#xD;
             coronary revascularization [percutaneous coronary intervention (PCI), coronary artery&#xD;
             bypass graft (CABG)] and other arterial revascularization procedures, ischaemic&#xD;
             stroke, peripheral arterial disease(PAD);&#xD;
&#xD;
          3. Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage&#xD;
             (such as microalbuminuria); Patients with moderate to severe chronic kidney disease&#xD;
             [glomerular filtration rate (GFR) &lt; 60 mL/min/1.73㎡];&#xD;
&#xD;
          4. Markedly elevated single risk factors such as familial dyslipidaemias and severe&#xD;
             hypertension;&#xD;
&#xD;
          5. A calculated SCORE ≥1% for 10 year risk of fatal CVD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cancer;&#xD;
&#xD;
          2. HIV infected;&#xD;
&#xD;
          3. Medical or psychiatric condition that prevents full study participation or follow-up&#xD;
             (e.g., active psychosis);&#xD;
&#xD;
          4. Active liver disease or unexplained persistent elevated transaminase levels；&#xD;
&#xD;
          5. Major surgery or hospitalization in the 3 months prior to study entry;&#xD;
&#xD;
          6. Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any &quot;azole&quot;&#xD;
             antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or&#xD;
             protease inhibitors;&#xD;
&#xD;
          7. Female of childbearing potential;&#xD;
&#xD;
          8. Severe gastrointestinal disease;&#xD;
&#xD;
          9. With berberine using contraindications;&#xD;
&#xD;
         10. Secondary hyperlipidemia&#xD;
&#xD;
         11. Current participation in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jifei Tang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wenzhou Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Second Hospital of Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>April 27, 2016</last_update_submitted>
  <last_update_submitted_qc>April 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Kangting Ji, MD</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</mesh_term>
    <mesh_term>Hyperlipidemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01697735
org study id: WZ medical college
nct id: NCT01697735
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Change from baseline in combination statins with berberine on lipid level
time frame: Measured at baseline, weeks 4 and 8
measure: Adherence of statins and berberine treatment
time frame: Measured at weeks 4 and 8
arm group label: Berberine;Atorvastatin or Rosuvastatin
arm group type: Experimental
description: 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.
arm group label: Atorvastatin or Rosuvastatin
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: Berberine;Atorvastatin or Rosuvastatin
description: 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.
arm group label: Berberine;Atorvastatin or Rosuvastatin
other name: Berberine;
other name: Liptor
other name: Crestor
intervention type: Drug
intervention name: Atorvastatin or Rosuvastatin
description: 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.
arm group label: Atorvastatin or Rosuvastatin
other name: Liptor
other name: Crestor
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jifei Tang, MD
role: Principal Investigator
affiliation: Wenzhou Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Kangting Ji, MD
investigator title: Director
mesh term: Dyslipidemias
mesh term: Hyperlipidemias
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium