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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01741974
Other study ID # IAR-KT-PERI
Secondary ID
Status Completed
Phase Phase 3
First received December 2, 2012
Last updated December 4, 2012
Start date October 2005
Est. completion date October 2012

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Karinat

Drug:
Placebo
Sugar pill manufactured to mimic Karinat 500 mg tablet

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institute for Atherosclerosis Research, Russia

Outcome

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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