The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin

Dyslipidemias Clinical Trial

Official title:

Comparison Between XueZhiKang and Simvastatin on Fatigue: a Single-center, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686451
• Other study ID #: Wenzhou
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2012
• Last updated: April 20, 2014
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: April 2014
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• XueZhiKang
Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
• simvastatin
Participants will receive 20mg of simvastatin daily for 4 weeks.

Locations

Country	Name	City	State
China	Second Hispital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of XueZhiKang With Simvastatin of Physical Activity Level	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.	Measured at baseline and week 4	No
Other	Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups	Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.	Measured at baseline and week 4	Yes
Other	Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group	Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.	Measured at baseline and week 4	Yes
Other	Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group	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.	Measured at baseline and week 4	No
Primary	Comparison Between XueZhiKang and Simvastatin on Fatigue Scores	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.	Measured at baseline and week 4	No
Secondary	Treatment Efficacy	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.	Measured at baseline and week 4	No