The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin

NCT ID: NCT01686451

Last Updated: 2014-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-09-30

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.

Conditions

Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

XueZhiKang

Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.

Group Type: EXPERIMENTAL

XueZhiKang

Intervention Type: DRUG

Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.

Simvastatin

Participants will receive 20mg of simvastatin daily for 4 weeks.

Group Type: ACTIVE_COMPARATOR

simvastatin

Intervention Type: DRUG

Participants will receive 20mg of simvastatin daily for 4 weeks.

Interventions

XueZhiKang

Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.

Intervention Type: DRUG

simvastatin

Participants will receive 20mg of simvastatin daily for 4 weeks.

Intervention Type: DRUG

Other Intervention Names

shujiangzhi

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

JiFei Tang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jifei Tang, MD

Role: PRINCIPAL_INVESTIGATOR

Wenzhou Medical University

Locations

Second Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 28521773 (View on PubMed)

Other Identifiers

Wenzhou

Identifier Type: -

Identifier Source: org_study_id