The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin

NCT01686451 | Completed Phase 4 Results

• 1 other identifier: Wenzhou
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Treatment Efficacy

  Measured at baseline and week 4

Other Outcomes (4)

• Comparison of XueZhiKang With Simvastatin of Physical Activity Level

  Measured at baseline and week 4

• Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups

  Measured at baseline and week 4

• Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group

  Measured at baseline and week 4

Study Arms (2)

XueZhiKang

EXPERIMENTAL

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

Drug: XueZhiKang

Simvastatin

ACTIVE COMPARATOR

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

Drug: simvastatin

Interventions

XueZhiKang DRUG

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

XueZhiKang

simvastatin DRUG

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

Also known as: shujiangzhi

Simvastatin

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Second Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

• 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.

  PMID: 28521773 DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

xuezhikang; Simvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

There are some limitations to this research. First, the sample size was relative small. Second, the follow-up period was short (4 weeks).

Results Point of Contact

• Title: Dr. JiFei Tang
• Organization: Department of Cardiology, the Second Affiliated Hospital, Wenzhou Medical University, Zhejiang province, Wenzhou, 325000, China

jiftang@126.com

+8615968766021

Study Officials

• Jifei Tang, MD

  Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 18, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 19, 2014
• Results First Posted: May 19, 2014

Record last verified: 2014-04

Locations

CN (1)