The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Intervention: XueZhiKang; simvastatin
Intervention description: Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.; Participants will receive 20mg of simvastatin daily for 4 weeks.
Intervention MeSH terms: Simvastatin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. LDL cholesterol level between 115-190 mg/dL;

          2. Able to fast prior to blood draw;

          3. Able to comfortably read and write in Chinese;

          4. Able and willing to refrain from donating whole blood during study participation;

          5. Willing to abstain from consuming large amounts of grapefruit juice.

        Exclusion 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);

          4. Patients with moderate to severe chronic kidney disease [glomerular filtration rate
             (GFR) < 60 mL/min/1.73㎡];

          5. Markedly elevated single risk factors such as familial dyslipidaemias and severe
             hypertension;

          6. A calculated SCORE ≥5% for 10 year risk of fatal CVD;

          7. Cancer;

          8. HIV infected;

          9. Medical or psychiatric condition that prevents full study participation or follow-up
             (e.g., active psychosis);

         10. Active liver disease or unexplained persistent elevated transaminase levels；

         11. Major surgery or hospitalization in the 3 months prior to study entry;

         12. Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole"
             antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or
             protease inhibitors;

         13. Female of childbearing potential;

         14. Current participation in another clinical trial.