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The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin

This study is currently recruiting participants.
Verified September 2012 by Wenzhou Medical College
Sponsor:
Information provided by (Responsible Party):
JiFei Tang, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01686451
First received: September 3, 2012
Last updated: November 2, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Dyslipidemias
 Drug: XueZhiKang
Drug: simvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Comparison Between XueZHiKang and Simvastatin on Fatigue: a Single-center, Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Fatigue
Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Wenzhou Medical College:

Primary Outcome Measures:
  • Change from baseline in comparison between XueZHiKang and simvastatin on fatigue [ Time Frame: Measured at baseline, weeks 4 and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence of XueZhiKang and simvastatin treatment [ Time Frame: Measured at weeks 4 and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XueZhiKang
Participants will receive 600mg of XueZhiKang twice a day for 8 weeks.
 Drug: XueZhiKang
Participants will receive 600mg of XueZhiKang twice a day for 8 weeks.
Other Name: XueZhiKang
Active Comparator: Simvastatin
Participants will receive 20mg of simvastatin daily for 8 weeks.
 Drug: simvastatin
Participants will receive 20mg of simvastatin daily for 8 weeks.
Other Name: shujiangzhi

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 8 weeks. Study visits will occur at baseline and Weeks 4 and 8. Blood will be collected for laboratory testing, and standardized psychological questionnaires will assess fatigue at baseline and weeks 4 and 8. Pill count will be used to assess adherence of XueZhiKang and simvastatin treatment at weeks 4 and 8. At weeks 4 and 8, medication side effects will be monitored and tests of alanine aminotransferase (ALT) and creatine phosphate kinase (CPK) will be performed. At weeks 4 and 8, medication efficacy will be assessed and test of low-density lipoprotein cholesterol (LDL-C) will be performed.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686451

Contacts
Contact: JiFei Tang, master 15968766021 497486104@qq.com

Locations
China, Zhejiang
Second Hispital of Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: JiFei Tang, Master     15968766021     497486104@qq.com    
Contact: Kangting Ji, Master     13676403180     heywyi@163.com    
Sponsors and Collaborators
Wenzhou Medical College
Investigators
Principal Investigator: Jifei Tang, MD Wenzhou Medical College
  More Information

No publications provided

Responsible Party: JiFei Tang, Director, Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01686451     History of Changes
Other Study ID Numbers: Wenzhou
Study First Received: September 3, 2012
Last Updated: November 2, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013