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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
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The purpose of this study is to assess the clinical efficacy and safety of policosanol on elderly patients with endothelial dysfunction
100 selected elderly patients with endothelial dysfunction were randomized to two groups,Group1:received policosanol 20mg qd;Group2:received placebo 20mg qdï¼›endothelial function was tested by peripheral arterial tonometry(PAT) before and after 6 months' treatment with policosanol or placebo respectively; Endothelial dysfunction is defined as reactive hyperemia index(RHI)< 1.67; The aim of this study is to assess the clinical efficacy and safety of policosanol on elderly patients with endothelial dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| policosanol | Experimental | Patients will receive policosanol 20mg daily until the end of the trial. |
|
| placebo | Placebo Comparator | Patients will receive placebo 20mg daily until the end of the trial; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| policosanol | Drug | Patients will receive policosanol 20mg Qd |
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| Measure | Description | Time Frame |
|---|---|---|
| reactive hyperemia index (RHI) measured by Endo-PAT | Novel digital pulse amplitude tonometry (PAT) offers the possibility of an easy and rapid assessment of vascular function. Endothelial function was assessed using a Endo-PAT device (Itamar Medical Ltd, Caesarea, Israel)and recorded as a reactive hyperemia index (RHI) | 6 months after the treatment with policosanol or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Policosanol in Older Patients | Triglyceride(TG),total cholesterol (TC), low-density lipoprotein(LDL-C), high- density lipoprotein cholesterol (HDL-C ), lipoprotein (a), apolipoprotein AI (apo AI) and apolipoprotein B (apo B) were measured at the clinical biochemistry. | 6 months after the treatment with policosanol or placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ping ye, M.D | Contact | 86-10-57976872 | dodyy0601@163.com | |
| yuanyuan duan, M.M | Contact | 86-10-57976873 |
| Name | Affiliation | Role |
|---|---|---|
| ping ye, M.D | Department of geriatric Cardiology, Chinese PLA general hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of South, General Hospital of Chinese People's Armed Police Forces | Recruiting | Beijing | Beijing Municipality | 100039 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20550469 | Result | Reriani MK, Lerman LO, Lerman A. Endothelial function as a functional expression of cardiovascular risk factors. Biomark Med. 2010 Jun;4(3):351-60. doi: 10.2217/bmm.10.61. | |
| 19699071 | Result | Affuso F, Ruvolo A, Micillo F, Sacca L, Fazio S. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):656-61. doi: 10.1016/j.numecd.2009.05.017. Epub 2009 Aug 20. |
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| ID | Term |
|---|---|
| C080710 | policosanol |
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| placebo | Drug | Patients will receive placebo 20mg Qd; |
|
| the safety of policosanol evaluated by clinical and statistical analysis, including clinical adverse reactions, laboratory indexes (such as liver function, kidney function and creatine kinase (CK) value) and vital signs |
The safety was evaluated by clinical and statistical analysis, including clinical adverse reactions, laboratory indexes (such as liver function, kidney function and creatine kinase (CK) value) and vital signs. |
| 6 months after the treatment with policosanol or placebo |
| 19552735 | Result | Faizi AK, Kornmo DW, Agewall S. Evaluation of endothelial function using finger plethysmography. Clin Physiol Funct Imaging. 2009 Sep;29(5):372-5. doi: 10.1111/j.1475-097X.2009.00882.x. Epub 2009 Jun 22. |
| 17887938 | Result | Noa M, Mas R, Lariot C. Protective effect of policosanol on endothelium and intimal thickness induced by forceps in rabbits. J Med Food. 2007 Sep;10(3):452-9. doi: 10.1089/jmf.2006.232. |
| 22500237 | Result | Moerland M, Kales AJ, Schrier L, van Dongen MG, Bradnock D, Burggraaf J. Evaluation of the EndoPAT as a Tool to Assess Endothelial Function. Int J Vasc Med. 2012;2012:904141. doi: 10.1155/2012/904141. Epub 2012 Feb 14. |
| 24945081 | Result | Vizzardi E, Gavazzoni M, Della Pina P, Bonadei I, Regazzoni V, Sciatti E, Trichaki E, Raddino R, Metra M. Noninvasive assessment of endothelial function: the classic methods and the new peripheral arterial tonometry. J Investig Med. 2014 Aug;62(6):856-64. doi: 10.1097/JIM.0000000000000096. |
| 22402933 | Result | Onkelinx S, Cornelissen V, Goetschalckx K, Thomaes T, Verhamme P, Vanhees L. Reproducibility of different methods to measure the endothelial function. Vasc Med. 2012 Apr;17(2):79-84. doi: 10.1177/1358863X12436708. Epub 2012 Mar 8. |