The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): XueZhiKang; simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.; Participants will receive 20mg of simvastatin daily for 4 weeks.
Other intervention name(s): shujiangzhi
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)