Efficacy and Safety Study of Policosanol

Study Overview
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Brief Summary
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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

Detailed Description
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100 selected elderly patients with endothelial dysfunction were randomized to two groups,Group1:received policosanol 20mg qd;Group2:received placebo 20mg qd；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.

Official Title
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The Effect of Policosanol on Elderly Patients With Endothelial Dysfunction

Conditions
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Endothelial Dysfunction

Intervention / Treatment
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* Drug: policosanol
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 60 years old； Patients with endothelial dysfunction Provision of informed consent prior to any study specific procedures. Exclusion Criteria: Acute myocardial infarction ,severe trauma , major operation or stroke within six months; Tumor or inflammatory diseases Known allergies to policosanol Life expectancy less than 1 year secondary dyslipidemia 6.taking other experimental medicine within six months;

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: policosanol<br>Patients will receive policosanol 20mg daily until the end of the trial. | Drug: policosanol<br>* Patients will receive policosanol 20mg Qd<br>* Other names: ateromixol;|
| Placebo Comparator: placebo<br>Patients will receive placebo 20mg daily until the end of the trial; | Drug: placebo<br>* Patients will receive placebo 20mg Qd;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, policosanol, efficacy, safety