NCT01734707

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
Last Updated

November 28, 2012

Status Verified

January 1, 2005

Enrollment Period

1 year

First QC Date

November 16, 2012

Last Update Submit

November 21, 2012

Conditions

Carotid Atherosclerosis

Keywords

atherosclerosisregressionAllicorgarlicintima-media thickness

Outcome Measures

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

    up to 2 years

Secondary Outcomes (1)

  • Measure of serum atherogenicity

    up to 2 years

Study Arms (2)

Allicor

ACTIVE COMPARATOR

Allicor 150 mg tablet by mouth two times a day

Dietary Supplement: Allicor

Sugar pill

PLACEBO COMPARATOR

Placebo tablet 150 mg by mouth two times a day

Drug: Placebo

Interventions

AllicorDIETARY_SUPPLEMENT
Also known as: time-released garlic powder tablets
Allicor
PlaceboDRUG

Sugar pill manufactured to mimic Allicor 150 mg tablet

Sugar pill

Eligibility Criteria

Age40 Years - 74 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Personal history or diagnostic of following diseases:
  • Transient ischemic attacks
  • Presence of chronic diseases demanding permanent drug administration (more than 2 month per year)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Atherosclerosis Research

Moscow, Moscow, Russia

Location

Related Publications (1)

  • 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.

    PMID: 20958974RESULT

MeSH Terms

Conditions

Carotid Artery DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2012

First Posted

November 28, 2012

Study Start

January 1, 2004

Primary Completion

January 1, 2005

Study Completion

October 1, 2005

Last Updated

November 28, 2012

Record last verified: 2005-01

Locations

RU(1)