Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women (PEARS-POST)

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

The purpose of this study is to investigate the anti-atherosclerotic action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis
• Intervention / Treatment: Dietary supplement: Karinat; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sugar pill; Placebo 500 mg tablet by mouth three times a day	Drug: Placebo; Sugar pill manufactured to mimic Karinat 500 mg tablet
Active Comparator: Karinat; Karinat 500 mg tablet by mouth three times a day	Dietary supplement: Karinat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B-mode ultrasound of carotid arteries	Variation of intima-media thickness of common carotid arteries	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of serum atherogenicity	Change of the ability of serum to induce cholesterol accumulation in cultured cells	up to 2 years

Collaborators and Investigators

• Sponsor: Institute for Atherosclerosis Research, Russia

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: December 2, 2012
• First Submitted That Met QC Criteria: December 2, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: atherosclerosis; phytoestrogen; postmenopause; intima-media thickness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: IAR-KT-POST