Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women

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

Official Title
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Double-blinded Placebo-controlled Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women

Conditions
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Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: Karinat
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks Pulmonary thromboembolism Chronic heart failure IIa-III Uncontrolled arterial hypertension (systolic blood pressure > 145 mmHg, diastolic blood pressure > 95 mmHg under hypotensive therapy) Malignancy Chronic renal failure II-III Chronic hepatic failure II-III Liver cirrhosis Individual intolerance of Karinat or major side effects
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Karinat<br>Karinat 500 mg tablet by mouth three times a day | Dietary Supplement: Karinat<br> <br> |
| Placebo Comparator: Sugar pill<br>Placebo 500 mg tablet by mouth three times a day | Drug: Placebo<br>* Sugar pill manufactured to mimic Karinat 500 mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B-mode ultrasound of carotid arteries | Variation of intima-media thickness of common carotid arteries | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of serum atherogenicity | Change of the ability of serum to induce cholesterol accumulation in cultured cells | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopause, phytoestrogen, atherosclerosis, intima-media thickness