Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women

Phase 3

Completed

• Conditions: Atherosclerosis
• Interventions: Dietary Supplement: Karinat; Drug: Placebo

• Registration Number: NCT01742000
• Lead Sponsor: Institute for Atherosclerosis Research, Russia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2012-06
• Status Verified: 2012-09
• Study Completion: 2012-10
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-02
• Last Update Submitted: 2012-12-04
• Study First Posted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Karinat	Karinat	Karinat 500 mg tablet by mouth three times a day
Sugar pill	Placebo	Placebo 500 mg tablet by mouth three times a day

Primary Outcome Measures

Name	Time	Method
B-mode ultrasound of carotid arteries	up to 2 years	Variation of intima-media thickness of common carotid arteries

Secondary Outcome Measures

Name	Time	Method
Measure of serum atherogenicity	up to 2 years	Change of the ability of serum to induce cholesterol accumulation in cultured cells