Efficacy and Safety Study of Policosanol

General Hospital of Chinese Armed Police Forces

Status and phase: Unknown; Phase 3

Conditions: Endothelial Dysfunction

Treatments: Drug: placebo; Drug: policosanol

Study type: Interventional

Funder types: Other

Identifiers

NCT02543099

20150811

Details and patient eligibility

About

The purpose of this study is to assess the clinical efficacy and safety of policosanol on elderly patients with endothelial dysfunction

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age over 60 years old；
2. Patients with endothelial dysfunction
3. Provision of informed consent prior to any study specific procedures.

Exclusion criteria

1. Acute myocardial infarction ,severe trauma , major operation or stroke within six months;
2. Tumor or inflammatory diseases
3. Known allergies to policosanol
4. Life expectancy less than 1 year
5. secondary dyslipidemia 6.taking other experimental medicine within six months;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

policosanol

Experimental group

Description:

Patients will receive policosanol 20mg daily until the end of the trial.

Treatment:

Drug: policosanol

placebo

Placebo Comparator group

Description:

Patients will receive placebo 20mg daily until the end of the trial;

Treatment:

Drug: placebo