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

Atherosclerosis Clinical Trial

— PEARS  

Official title:

Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741974
• Other study ID #: IAR-KT-PERI
• 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

• Atherosclerosis
• Menopausal Syndrome

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