Atherosclerosis Monitoring and Atherogenicity Reduction Study

NCT ID: NCT01734707

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-10-31

Brief Summary

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This study was designed to estimate the effect of two-year treatment with time-released garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial.

Detailed Description

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Conditions

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Carotid Atherosclerosis

Keywords

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atherosclerosis regression Allicor garlic intima-media thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Allicor

Allicor 150 mg tablet by mouth two times a day

Group Type ACTIVE_COMPARATOR

Allicor

Intervention Type DIETARY_SUPPLEMENT

Sugar pill

Placebo tablet 150 mg by mouth two times a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pill manufactured to mimic Allicor 150 mg tablet

Interventions

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Allicor

Intervention Type DIETARY_SUPPLEMENT

Placebo

Sugar pill manufactured to mimic Allicor 150 mg tablet

Intervention Type DRUG

Other Intervention Names

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time-released garlic powder tablets

Eligibility Criteria

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Inclusion Criteria

* Men aged 40 to 74 years
* Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 mcm)
* Arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm Hg, diastolic blood pressure \<90 mm Hg)
* Absence of chronic diseases demanding permanent drug administration (more than 2 month per year)

Exclusion Criteria

* Personal history or diagnostic of following diseases:

1. Transient ischemic attacks
2. Presence of chronic diseases demanding permanent drug administration (more than 2 month per year)
3. Condition of patients moderate to severe
* Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system.
* Individual intolerance of Allicor or appearance of side effects
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institute for Atherosclerosis Research, Russia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute for Atherosclerosis Research

Moscow, Moscow, Russia

Site Status

Countries

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Russia

References

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Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.

Reference Type RESULT
PMID: 20958974 (View on PubMed)

Other Identifiers

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IAR-AMAR

Identifier Type: -

Identifier Source: org_study_id