Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women

Atherosclerosis Clinical Trial

— PEARS-POST  

Official title:

Double-blinded Placebo-controlled Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742000
• Other study ID #: IAR-KT-POST
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2012
• Last updated: December 4, 2012
• Start date: January 2007
• Est. completion date: October 2012

Study information

• Verified date: September 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 action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

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 2 years	Yes
Secondary	Measure of serum atherogenicity	Change of the ability of serum to induce cholesterol accumulation in cultured cells	up to 2 years	Yes