The Effect of XueZhiKang on Fatigue:Comparing With Simvastatin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JiFei Tang, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01686451
First received: September 3, 2012
Last updated: April 20, 2014
Last verified: April 2014
  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:


Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • Comparison Between XueZhiKang and Simvastatin on Fatigue Scores [ Time Frame: Measured at baseline and week 4 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Treatment Efficacy [ Time Frame: Measured at baseline and week 4 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Comparison of XueZhiKang With Simvastatin of Physical Activity Level [ Time Frame: Measured at baseline and week 4 ] [ Designated as safety issue: No ]
    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.

  • Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups [ Time Frame: Measured at baseline and week 4 ] [ Designated as safety issue: Yes ]
    Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.

  • Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group [ Time Frame: Measured at baseline and week 4 ] [ Designated as safety issue: Yes ]
    Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.

  • Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group [ Time Frame: Measured at baseline and week 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XueZhiKang
Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
Drug: XueZhiKang
Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
Other Name: XueZhiKang
Active Comparator: Simvastatin
Participants will receive 20mg of simvastatin daily for 4 weeks.
Drug: simvastatin
Participants will receive 20mg of simvastatin daily for 4 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 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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01686451

Locations
China, Zhejiang
Second Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: Jifei Tang, MD Wenzhou Medical University
  More Information

No publications provided

Responsible Party: JiFei Tang, Director, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01686451     History of Changes
Other Study ID Numbers: Wenzhou
Study First Received: September 3, 2012
Results First Received: October 8, 2013
Last Updated: April 20, 2014
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on September 18, 2014