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CompletedNCT01734707Updated Nov 28, 2012

Atherosclerosis Monitoring and Atherogenicity Reduction Study

A Phase 3 interventional study of Allicor and Placebo in Carotid Atherosclerosis, sponsored by Institute for Atherosclerosis Research, Russia. Completed at 1 site in Russian Federation. Open to male participants aged 40 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-28.

Sponsored by Institute for Atherosclerosis Research, Russia · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
40 Years to 74 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Carotid Atherosclerosis

Keywords

  • atherosclerosis
  • regression
  • Allicor
  • garlic
  • intima-media thickness
03

In context

Carotid Artery Diseases

248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.

This study's enrollment of 300 is above the median of 120 across 118 interventional studies indexed under Carotid Artery Diseases.

Browse Carotid Artery Diseases studies →

Lead sponsor

Institute for Atherosclerosis Research, Russia is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 74 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
300 participants (actual)

Study arms

  • Active comparator
    Allicor

    Allicor 150 mg tablet by mouth two times a day

    Dietary Supplement: Allicor

  • Placebo comparator
    Sugar pill

    Placebo tablet 150 mg by mouth two times a day

    Drug: Placebo

Interventions

  • Dietary supplementAllicor

    Also known as: time-released garlic powder tablets

  • DrugPlacebo

    Sugar pill manufactured to mimic Allicor 150 mg tablet

06

What researchers measure

Primary outcomes

  1. high-resolution B-mode ultrasonography of common carotid arteries

    Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries

    Time frame: up to 2 years

Secondary outcomes

  1. Measure of serum atherogenicity

    Change of the ability of serum to induce cholesterol accumulation in cultured cells

    Time frame: up to 2 years

07

Study locations

1 site
  • Institute for Atherosclerosis Research
    Moscow, Russian Federation
08

References and documents

Publications

  • 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. PubMed 20958974 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01734707
Lead sponsor
Institute for Atherosclerosis Research, Russia
Responsible party
Sponsor
First posted
Nov 28, 2012
Start date
Jan 2004
Primary completion
Jan 2005
Completion
Oct 2005
Last update
Nov 28, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2005. You cannot join it, but the record below documents what was studied.

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