Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to investigate the anti-atherosclerotic action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute for Atherosclerosis Research, Russia
• Treatments: alpha-Tocopherol; Ascorbic Acid; Beta Carotene

Criteria

Inclusion Criteria:

• Women at least 5 years after menopause

• Maximum intima-media thickness of common carotid artery more than 0,80 mm (ultrasonographic B-mode examination)

• The absence of climacteric syndrome (less than 3 points by Blatt-Kupperman scale)

• The absence of chronic diseases demanding permanent drug administration (more than 2 month per year)

• The absence of hypolipidemic therapy or hormone replacement therapy during 6 months before the inclusion

Exclusion Criteria:

• Administration of lipid-lowering drugs, and/or hormone replacement therapy, and/or phytoestrogens during 6 month before inclusion

• Continuous administration of sulfonylurea derivatives, and/or beta-blockers, and/or calcium antagonists (more than 2 months per year)

• Personal history or diagnostic of following diseases:

1. Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks

2. Pulmonary thromboembolism

3. Chronic heart failure IIa-III

4. Uncontrolled arterial hypertension (systolic blood pressure > 145 mmHg, diastolic blood pressure > 95 mmHg under hypotensive therapy)

5. Malignancy

6. Chronic renal failure II-III

7. Chronic hepatic failure II-III

8. Liver cirrhosis

9. Individual intolerance of Karinat or major side effects