Phase 4
N=60
The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin
Dyslipidemias
Bottom Line
View on ClinicalTrials.gov: NCT01686451 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Comparison Between XueZhiKang and Simvastatin on Fatigue Scores — 19.58; 21.58; 19.26; 19.33 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- XueZhiKang (Drug); simvastatin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Wenzhou Medical University
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison Between XueZhiKang and Simvastatin on Fatigue Scores |
19.58; 21.58; 19.26; 19.33 | — |
| SECONDARY Treatment Efficacy |
1.76; 1.54; 1.61; 1.36; 5.91; 4.73 | — |
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.
Eligibility Criteria
Inclusion Criteria
- LDL cholesterol level between 115-190 mg/dL;
- Able to fast prior to blood draw;
- Able to comfortably read and write in Chinese;
- Able and willing to refrain from donating whole blood during study participation;
- Willing to abstain from consuming large amounts of grapefruit juice.
Exclusion Criteria
- Current use of lipid-lowering medications;
- 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);
- Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria);
- Patients with moderate to severe chronic kidney disease [glomerular filtration rate (GFR) < 60 mL/min/1.73㎡];
- Markedly elevated single risk factors such as familial dyslipidaemias and severe hypertension;
- A calculated SCORE ≥5% for 10 year risk of fatal CVD;
- Cancer;
- HIV infected;
- Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis);
- Active liver disease or unexplained persistent elevated transaminase levels；
- Major surgery or hospitalization in the 3 months prior to study entry;
- Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole" antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or protease inhibitors;
- Female of childbearing potential;
- Current participation in another clinical trial.
Data sourced from ClinicalTrials.gov (NCT01686451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.