Clinical trial NCT01686451: The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin
Official title: Comparison Between XueZhiKang and Simvastatin on Fatigue: a Single-center, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemias
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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.

Primary outcomes:
measure: Comparison Between XueZhiKang and Simvastatin on Fatigue Scores
timeFrame: Measured at baseline and week 4
Secondary outcomes:
measure: Treatment Efficacy
timeFrame: Measured at baseline and week 4
Other outcomes:
measure: Comparison of XueZhiKang With Simvastatin of Physical Activity Level
timeFrame: Measured at baseline and week 4
measure: Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups
timeFrame: Measured at baseline and week 4
measure: Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group
timeFrame: Measured at baseline and week 4
measure: Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group
timeFrame: Measured at baseline and week 4
Locations:
city: Wenzhou
country: China
facility: Second Hispital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: Jifei Tang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xue Y, Tao L, Wu S, Wang G, Qian L, Li J, Liao L, Tang J, Ji K. Red yeast rice induces less muscle fatigue symptom than simvastatin in dyslipidemic patients: a single center randomized pilot trial. BMC Cardiovasc Disord. 2017 May 18;17(1):127. doi: 10.1186/s12872-017-0560-z.