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Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis

Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01743404
Enrollment
300
Registered
2012-12-06
Start date
2007-09-30
Completion date
2013-06-30
Last updated
2012-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Atherosclerosis

Keywords

atherosclerosis, inflammation, intima-media thickness

Brief summary

The purpose of this study is to investigate the anti-atherosclerotic effect of long-term anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical atherosclerosis of carotid arteries.

Interventions

DIETARY_SUPPLEMENTInflaminat
DRUGPlacebo

Sugar pill manufactured to mimic Inflaminat 500 mg tablet

Sponsors

Institute for Atherosclerosis Research, Russia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Men aged 40 to 70 years * Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1000-2000 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 of stroke or transient ischemic attacks * Chronic diseases demanding drug administration more than during 2 month per year * Individual intolerance of Inflaminat or appearance of side effects

Design outcomes

Primary

MeasureTime frameDescription
B-mode ultrasound of carotid arteriesup to 2 yearsVariation of intima-media thickness of common carotid arteries

Secondary

MeasureTime frameDescription
Measure of serum atherogenicityup to 2 yearsChange of the ability of serum to induce cholesterol accumulation in cultured cells

Countries

Russia

Contacts

Primary ContactIgor Sobenin, MD
igor.sobenin@gmail.com+79263590050
Backup ContactEkaterina Chernova
katrincorde@gmail.com+79166647123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026