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Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women (PEARS-POST)

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ClinicalTrials.gov Identifier: NCT01742000
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Institute for Atherosclerosis Research, Russia

Brief 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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Dietary Supplement: Karinat Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Double-blinded Placebo-controlled Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
Study Start Date : January 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Active Comparator: Karinat
Karinat 500 mg tablet by mouth three times a day
Dietary Supplement: Karinat
Placebo Comparator: Sugar pill
Placebo 500 mg tablet by mouth three times a day
Drug: Placebo
Sugar pill manufactured to mimic Karinat 500 mg tablet




Primary Outcome Measures :
  1. B-mode ultrasound of carotid arteries [ Time Frame: up to 2 years ]
    Variation of intima-media thickness of common carotid arteries


Secondary Outcome Measures :
  1. Measure of serum atherogenicity [ Time Frame: up to 2 years ]
    Change of the ability of serum to induce cholesterol accumulation in cultured cells



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Institute for Atherosclerosis Research, Russia
ClinicalTrials.gov Identifier: NCT01742000     History of Changes
Other Study ID Numbers: IAR-KT-POST
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: September 2012
Keywords provided by Institute for Atherosclerosis Research, Russia:
postmenopause
phytoestrogen
atherosclerosis
intima-media thickness
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ascorbic Acid
Beta Carotene
alpha-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Provitamins