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

Phase 2

• Conditions: Carotid Atherosclerosis
• Interventions: Dietary Supplement: Inflaminat; Drug: Placebo

• Registration Number: NCT01743404
• Lead Sponsor: Institute for Atherosclerosis Research, Russia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Status Verified: 2012-09
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-04
• Last Update Submitted: 2012-12-04
• Study First Posted: 2012-12-06
• Last Update Posted: 2012-12-06
• Primary Completion: 2013-02
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inflaminat	Inflaminat	Inflaminat 500 mg tablet by mouth three times a day
Sugar pill	Placebo	Placebo 500 mg tablet by mouth three times a day

Primary Outcome Measures

Name	Time	Method
B-mode ultrasound of carotid arteries	up to 2 years	Variation of intima-media thickness of common carotid arteries

Secondary Outcome Measures

Name	Time	Method
Measure of serum atherogenicity	up to 2 years	Change of the ability of serum to induce cholesterol accumulation in cultured cells

Trial Locations

Locations (1)

Institute for Atherosclerosis Research; 🇷🇺 Moscow, Russian Federation