Carotid Atherosclerosis
Conditions
Keywords
atherosclerosis, regression, Allicor, garlic, intima-media thickness
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.
Interventions
DIETARY_SUPPLEMENTAllicor
DRUGPlacebo
Sugar pill manufactured to mimic Allicor 150 mg tablet
Sponsors
Institute for Atherosclerosis Research, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
40 Years to 74 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| high-resolution B-mode ultrasonography of common carotid arteries | up to 2 years | Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of serum atherogenicity | up to 2 years | Change of the ability of serum to induce cholesterol accumulation in cultured cells |
Countries
Russia
Outcome results
None listed