<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/NCT01686451</url>
  </required_header>
  <id_info>
    <org_study_id>Wenzhou</org_study_id>
    <nct_id>NCT01686451</nct_id>
  </id_info>
  <brief_title>The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin</brief_title>
  <official_title>Comparison Between XueZhiKang and Simvastatin on Fatigue: a Single-center, Randomized 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>
      Both XueZhiKang and Statins are cholesterol-lowering medications that are often prescribed&#xD;
      for individuals with high cholesterol and who are at risk for cardiovascular disease (CVD).&#xD;
      Several studies, including one randomized, double-blind, placebo-controlled clinical trial,&#xD;
      have suggested that the use of statins is more frequently associated with fatigue. And&#xD;
      XueZhiKang may be not. The purpose of this study is to compare the effect of these two&#xD;
      medications on fatigue in persons who are at moderate to low CVD risk based on the risk&#xD;
      estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis&#xD;
      Society) guidelines (2011) for the management of dyslipidemias.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals 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 individuals have a lower incidence of coronary artery disease, ischemic stroke,&#xD;
      and peripheral arterial disease and so on. While statins are effective at lowering&#xD;
      cholesterol levels, their effect on fatigue is obvious and has been suggested by several&#xD;
      studies, including one randomized, double-blind, placebo-controlled clinical trial. And&#xD;
      XueZhiKang may be not. The purpose of this study is to compare the effect of these two&#xD;
      medications on fatigue in persons who are at moderate to low CVD risk based on the risk&#xD;
      estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis&#xD;
      Society) guidelines (2011) for the management of dyslipidemias.&#xD;
&#xD;
      This study will enroll individuals who do not currently take cholesterol-lowering&#xD;
      medications. Participants will be randomly assigned to receive 600mg of XueZhiKang twice a&#xD;
      day, or 20mg of simvastatin daily for 4 weeks. Study visits will occur at baseline and Week&#xD;
      4. Blood will be collected for laboratory testing, and standardized psychological&#xD;
      questionnaires will assess fatigue scores and physical activity levels at baseline and week&#xD;
      4. Pill count will be used to assess adherence of XueZhiKang and simvastatin treatment at&#xD;
      week 4. At week 4, medication side effects will be monitored and tests of alanine&#xD;
      aminotransferase (ALT), aspartate aminotransaminase (AST) and creatine phosphate kinase (CPK)&#xD;
      will be performed. At week 4, medication efficacy will be assessed and test of low-density&#xD;
      lipoprotein cholesterol (LDL-C) will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison Between XueZhiKang and Simvastatin on Fatigue Scores</measure>
    <time_frame>Measured at baseline and week 4</time_frame>
    <description>At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment Efficacy</measure>
    <time_frame>Measured at baseline and week 4</time_frame>
    <description>Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Comparison of XueZhiKang With Simvastatin of Physical Activity Level</measure>
    <time_frame>Measured at baseline and week 4</time_frame>
    <description>At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups</measure>
    <time_frame>Measured at baseline and week 4</time_frame>
    <description>Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group</measure>
    <time_frame>Measured at baseline and week 4</time_frame>
    <description>Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group</measure>
    <time_frame>Measured at baseline and week 4</time_frame>
    <description>We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>XueZhiKang</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XueZhiKang</intervention_name>
    <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
    <arm_group_label>XueZhiKang</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>simvastatin</intervention_name>
    <description>Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
    <arm_group_label>Simvastatin</arm_group_label>
    <other_name>shujiangzhi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. LDL cholesterol level between 115-190 mg/dL;&#xD;
&#xD;
          2. Able to fast prior to blood draw;&#xD;
&#xD;
          3. Able to comfortably read and write in Chinese;&#xD;
&#xD;
          4. Able and willing to refrain from donating whole blood during study participation;&#xD;
&#xD;
          5. Willing to abstain from consuming large amounts of grapefruit juice.&#xD;
&#xD;
        Exclusion 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);&#xD;
&#xD;
          4. Patients with moderate to severe chronic kidney disease [glomerular filtration rate&#xD;
             (GFR) &lt; 60 mL/min/1.73㎡];&#xD;
&#xD;
          5. Markedly elevated single risk factors such as familial dyslipidaemias and severe&#xD;
             hypertension;&#xD;
&#xD;
          6. A calculated SCORE ≥5% for 10 year risk of fatal CVD;&#xD;
&#xD;
          7. Cancer;&#xD;
&#xD;
          8. HIV infected;&#xD;
&#xD;
          9. Medical or psychiatric condition that prevents full study participation or follow-up&#xD;
             (e.g., active psychosis);&#xD;
&#xD;
         10. Active liver disease or unexplained persistent elevated transaminase levels；&#xD;
&#xD;
         11. Major surgery or hospitalization in the 3 months prior to study entry;&#xD;
&#xD;
         12. 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;
         13. Female of childbearing potential;&#xD;
&#xD;
         14. Current participation in another clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 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 Hispital of Wenzhou Medical University</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 2014</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>October 8, 2013</results_first_submitted>
  <results_first_submitted_qc>April 20, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 19, 2014</results_first_posted>
  <last_update_submitted>April 20, 2014</last_update_submitted>
  <last_update_submitted_qc>April 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>JiFei Tang</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simvastatin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>From August 10, 2012, through September 15, 2013, 243 patients were screened and 60 patients who met the inclusion criteria were enrolled and randomly assigned to either simvastatin (33 patients) or xuezhikang (27 patients) at medical clinic.</recruitment_details>
      <pre_assignment_details>183 eligible patients were excluded with 160 patients declined to participate while 19 patients were currently using lipid-lowering medications, 3 patients were suffering from chronic kidney disease or active liver disease and 1 was of currently childbearing.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Simvastatin</title>
          <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
        </group>
        <group group_id="P2">
          <title>XueZhiKang</title>
          <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 60 patients with dyslipidemia and moderate to low cardiovascular disease (CVD) risk were randomly assigned in an open label fashion to receive either simvastatin (n=33) 20 mg daily or xuezhikang (n=27) 600 mg twice daily. All 60 patients were included in baseline analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Simvastatin</title>
          <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
        </group>
        <group group_id="B2">
          <title>XueZhiKang</title>
          <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.18" spread="7.00"/>
                    <measurement group_id="B2" value="47.04" spread="5.83"/>
                    <measurement group_id="B3" value="46.57" spread="6.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current cigarette smoker, Categorical</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Current cigarette smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Current cigarette smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Arterial hypertension, Categorical</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Arterial hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Arterial hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Arterial blood pressure, Continuous</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="148.06" spread="18.51"/>
                    <measurement group_id="B2" value="147.89" spread="17.03"/>
                    <measurement group_id="B3" value="147.98" spread="17.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84.18" spread="6.95"/>
                    <measurement group_id="B2" value="83.00" spread="8.82"/>
                    <measurement group_id="B3" value="83.65" spread="7.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting blood glucose, Continuous</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.10" spread="0.36"/>
                    <measurement group_id="B2" value="5.33" spread="0.52"/>
                    <measurement group_id="B3" value="5.20" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglyceride, Continuous</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.76" spread="1.00"/>
                    <measurement group_id="B2" value="1.61" spread="0.65"/>
                    <measurement group_id="B3" value="1.69" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total cholesterol, Continuous</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.91" spread="0.71"/>
                    <measurement group_id="B2" value="5.82" spread="0.73"/>
                    <measurement group_id="B3" value="5.87" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High-density lipoprotein-cholesterol, Continuous</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.27" spread="0.25"/>
                    <measurement group_id="B2" value="1.23" spread="0.25"/>
                    <measurement group_id="B3" value="1.26" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Low-density lipoprotein-cholesterol, Continuous</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.72" spread="0.48"/>
                    <measurement group_id="B2" value="3.74" spread="0.55"/>
                    <measurement group_id="B3" value="3.73" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alanine aminotransferase, Continuous</title>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.58" spread="10.55"/>
                    <measurement group_id="B2" value="30.33" spread="13.30"/>
                    <measurement group_id="B3" value="29.37" spread="11.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Aspartate aminotransferase, Continuous</title>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.12" spread="7.00"/>
                    <measurement group_id="B2" value="25.63" spread="7.53"/>
                    <measurement group_id="B3" value="24.80" spread="7.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Creatine phosphate kinase, Continuous</title>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.82" spread="24.91"/>
                    <measurement group_id="B2" value="91.65" spread="23.71"/>
                    <measurement group_id="B3" value="85.69" spread="24.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Creatinine, Continuous</title>
          <units>μmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.57" spread="14.44"/>
                    <measurement group_id="B2" value="75.59" spread="17.20"/>
                    <measurement group_id="B3" value="73.93" spread="15.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fatigue score, Continuous</title>
          <description>The fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.58" spread="2.55"/>
                    <measurement group_id="B2" value="19.26" spread="1.85"/>
                    <measurement group_id="B3" value="19.43" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physical activity level, Categorical</title>
          <description>We estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Low level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Efficacy</title>
        <description>Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.</description>
        <time_frame>Measured at baseline and week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Simvastatin/Baseline</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin/Week 4</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>XueZhiKang/Baseline</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>XueZhiKang/Week 4</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Efficacy</title>
          <description>Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TG level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.76" spread="1.00"/>
                    <measurement group_id="O2" value="1.54" spread="1.01"/>
                    <measurement group_id="O3" value="1.61" spread="0.65"/>
                    <measurement group_id="O4" value="1.36" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TC level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.91" spread="0.71"/>
                    <measurement group_id="O2" value="4.73" spread="1.08"/>
                    <measurement group_id="O3" value="5.82" spread="0.73"/>
                    <measurement group_id="O4" value="4.72" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" spread="0.25"/>
                    <measurement group_id="O2" value="1.32" spread="0.36"/>
                    <measurement group_id="O3" value="1.23" spread="0.25"/>
                    <measurement group_id="O4" value="1.37" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.72" spread="0.48"/>
                    <measurement group_id="O2" value="2.54" spread="0.72"/>
                    <measurement group_id="O3" value="3.74" spread="0.55"/>
                    <measurement group_id="O4" value="2.45" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Comparison Between XueZhiKang and Simvastatin on Fatigue Scores</title>
        <description>At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.</description>
        <time_frame>Measured at baseline and week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Simvastatin/Baseline</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin/Week 4</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>XueZhiKang/Baseline</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>XueZhiKang/Week 4</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison Between XueZhiKang and Simvastatin on Fatigue Scores</title>
          <description>At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.58" spread="2.55"/>
                    <measurement group_id="O2" value="21.58" spread="2.75"/>
                    <measurement group_id="O3" value="19.26" spread="1.85"/>
                    <measurement group_id="O4" value="19.33" spread="1.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Comparison of XueZhiKang With Simvastatin of Physical Activity Level</title>
        <description>At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.</description>
        <time_frame>Measured at baseline and week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Simvastatin/Baseline</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin/Week 4</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>XueZhiKang/Baseline</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>XueZhiKang/Week 4</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of XueZhiKang With Simvastatin of Physical Activity Level</title>
          <description>At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Low level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups</title>
        <description>Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.</description>
        <time_frame>Measured at baseline and week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Simvastatin/Baseline</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin/Week 4</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>XueZhiKang/Baseline</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>XueZhiKang/Week 4</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups</title>
          <description>Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.</description>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.58" spread="10.55"/>
                    <measurement group_id="O2" value="28.73" spread="13.10"/>
                    <measurement group_id="O3" value="30.33" spread="13.30"/>
                    <measurement group_id="O4" value="28.67" spread="14.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.12" spread="6.99"/>
                    <measurement group_id="O2" value="24.42" spread="6.89"/>
                    <measurement group_id="O3" value="25.63" spread="7.53"/>
                    <measurement group_id="O4" value="25.85" spread="7.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CPK level at baseline and week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.82" spread="24.91"/>
                    <measurement group_id="O2" value="82.76" spread="33.80"/>
                    <measurement group_id="O3" value="91.65" spread="23.71"/>
                    <measurement group_id="O4" value="90.92" spread="24.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group</title>
        <description>Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.</description>
        <time_frame>Measured at baseline and week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Simvastatin/Baseline</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin/Week 4</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>XueZhiKang/Baseline</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>XueZhiKang/Week 4</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group</title>
          <description>Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.57" spread="14.44"/>
                    <measurement group_id="O2" value="71.95" spread="14.34"/>
                    <measurement group_id="O3" value="75.59" spread="17.20"/>
                    <measurement group_id="O4" value="76.51" spread="16.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group</title>
        <description>We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.</description>
        <time_frame>Measured at baseline and week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Simvastatin/Baseline</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin/Week 4</title>
            <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>XueZhiKang/Baseline</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>XueZhiKang/Week 4</title>
            <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group</title>
          <description>We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.</description>
          <units>number of pills</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="462"/>
                    <measurement group_id="O2" value="462"/>
                    <measurement group_id="O3" value="3024"/>
                    <measurement group_id="O4" value="3024"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Simvastatin</title>
          <description>Participants will receive 20mg of simvastatin daily for 4 weeks.&#xD;
simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks.</description>
        </group>
        <group group_id="E2">
          <title>XueZhiKang</title>
          <description>Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.&#xD;
XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>There are some limitations to this research. First, the sample size was relative small. Second, the follow-up period was short (4 weeks).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. JiFei Tang</name_or_title>
      <organization>Department of Cardiology, the Second Affiliated Hospital, Wenzhou Medical University, Zhejiang province, Wenzhou, 325000, China</organization>
      <phone>+8615968766021</phone>
      <email>jiftang@126.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01686451
org study id: Wenzhou
nct id: NCT01686451
lead sponsor: 
has dmc: No
Both XueZhiKang and Statins are cholesterol-lowering medications that are often prescribed
      for individuals with high cholesterol and who are at risk for cardiovascular disease (CVD).
      Several studies, including one randomized, double-blind, placebo-controlled clinical trial,
      have suggested that the use of statins is more frequently associated with fatigue. And
      XueZhiKang may be not. The purpose of this study is to compare the effect of these two
      medications on fatigue in persons who are at moderate to low CVD risk based on the risk
      estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis
      Society) guidelines (2011) for the management of dyslipidemias.
Individuals 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 individuals have a lower incidence of coronary artery disease, ischemic stroke,
      and peripheral arterial disease and so on. While statins are effective at lowering
      cholesterol levels, their effect on fatigue is obvious and has been suggested by several
      studies, including one randomized, double-blind, placebo-controlled clinical trial. And
      XueZhiKang may be not. The purpose of this study is to compare the effect of these two
      medications on fatigue in persons who are at moderate to low CVD risk based on the risk
      estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis
      Society) guidelines (2011) for the management of dyslipidemias.

      This study will enroll individuals who do not currently take cholesterol-lowering
      medications. Participants will be randomly assigned to receive 600mg of XueZhiKang twice a
      day, or 20mg of simvastatin daily for 4 weeks. Study visits will occur at baseline and Week
      4. Blood will be collected for laboratory testing, and standardized psychological
      questionnaires will assess fatigue scores and physical activity levels at baseline and week
      4. Pill count will be used to assess adherence of XueZhiKang and simvastatin treatment at
      week 4. At week 4, medication side effects will be monitored and tests of alanine
      aminotransferase (ALT), aspartate aminotransaminase (AST) and creatine phosphate kinase (CPK)
      will be performed. At week 4, medication efficacy will be assessed and test of low-density
      lipoprotein cholesterol (LDL-C) will be performed.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Comparison Between XueZhiKang and Simvastatin on Fatigue Scores
time frame: Measured at baseline and week 4
description: At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.
measure: Treatment Efficacy
time frame: Measured at baseline and week 4
description: Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.
measure: Comparison of XueZhiKang With Simvastatin of Physical Activity Level
time frame: Measured at baseline and week 4
description: At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.
measure: Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups
time frame: Measured at baseline and week 4
description: Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.
measure: Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group
time frame: Measured at baseline and week 4
description: Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.
measure: Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group
time frame: Measured at baseline and week 4
description: We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.
arm group label: XueZhiKang
arm group type: Experimental
description: Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
arm group label: Simvastatin
arm group type: Active Comparator
description: Participants will receive 20mg of simvastatin daily for 4 weeks.
intervention type: Drug
intervention name: XueZhiKang
description: Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
arm group label: XueZhiKang
intervention type: Drug
intervention name: simvastatin
description: Participants will receive 20mg of simvastatin daily for 4 weeks.
arm group label: Simvastatin
other name: shujiangzhi
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 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: JiFei Tang
investigator title: Director
mesh term: Dyslipidemias
mesh term: Simvastatin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There are some limitations to this research. First, the sample size was relative small. Second, the follow-up period was short (4 weeks).
point of contact: 