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Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women (PEARS)

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ClinicalTrials.gov Identifier: NCT01741974
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

Study Description
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Brief Summary:
The purpose of this study is to investigate the anti-atherosclerotic and anti-climacteric action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal women.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Study Start Date : October 2005
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

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


Outcome Measures
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Primary Outcome Measures :
  1. B-mode ultrasound of carotid arteries [ Time Frame: up to 3 years ]
    Variation of intima-media thickness of common carotid arteries


Secondary Outcome Measures :
  1. Measure of serum atherogenicity [ Time Frame: up to 3 years ]
    Change of the ability of serum to induce cholesterol accumulation in cultured cells


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Perimenopausal women aged 45 to 60 years with intact womb and ovaries
  • The absence of menstruations between 6 to 24 months
  • Last menstruation after the age of 40 years
  • Follicle-stimulating hormone (FSH) blood level ≥ 35 ng/ml
  • Mammography without nodal form of mastopathy or breast cancer signs
  • Absence of hypolipidemic therapy or HRT (hormone replacement therapy) during 6 months before the inclusion

Exclusion Criteria:

  • Administration of lipid-lowering drugs, and/or HRT, and/or phytoestrogens during 6 month before inclusion
  • Personal history or diagnostic of following diseases:

nodal form of mastopathy or breast cancer any cancer except non-melanoma skin cancer stroke or myocardial infarction chronic renal failure II-III chronic hepatic failure II-III liver cirrhosis chronic heart failure IIa-III exacerbation of chronic stomach or duodenal ulcer obesity (BMI >30 kg/m2) alcohol abuse uncontrolled arterial hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 90 mmHg) current cigarette smoking (>10 cigarettes a day) diabetes mellitus deep vein thrombosis or pulmonary embolism

  • Individual intolerance of Karinat or major side effects
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Institute for Atherosclerosis Research, Russia
ClinicalTrials.gov Identifier: NCT01741974    
Other Study ID Numbers: IAR-KT-PERI
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: January 2012
Keywords provided by Institute for Atherosclerosis Research, Russia:
perimenopause
phytoestrogen
atherosclerosis
intima-media thickness
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases