Atherosclerosis Clinical Trial
— PEARSOfficial title:
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Verified date | January 2012 |
Source | Institute for Atherosclerosis Research, Russia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Russia: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 340 |
Est. completion date | October 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Institute for Atherosclerosis Research, Russia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | B-mode ultrasound of carotid arteries | Variation of intima-media thickness of common carotid arteries | up to 3 years | Yes |
Secondary | Measure of serum atherogenicity | Change of the ability of serum to induce cholesterol accumulation in cultured cells | up to 3 years | Yes |
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