Skip to main content
OpenTrials
Completed

NCT Number: NCT01742000

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks
  • Pulmonary thromboembolism
  • Chronic heart failure IIa-III
  • Uncontrolled arterial hypertension (systolic blood pressure > 145 mmHg, diastolic blood pressure > 95 mmHg under hypotensive therapy)
  • Malignancy
  • Chronic renal failure II-III
  • Chronic hepatic failure II-III
  • Liver cirrhosis
  • Individual intolerance of Karinat or major side effects

Treatment and study plan

Karinat

Dietary Supplement

Placebo

Drug

Sugar pill manufactured to mimic Karinat 500 mg tablet

Primary outcomes

  1. B-mode ultrasound of carotid arteries

    Time frame: up to 2 years

    Variation of intima-media thickness of common carotid arteries

Secondary outcomes

  1. Measure of serum atherogenicity

    Time frame: up to 2 years

    Change of the ability of serum to induce cholesterol accumulation in cultured cells

Sponsors and collaborators

Lead sponsor

Institute for Atherosclerosis Research, Russia

Other

Registry information

Official study title

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

Acronym: PEARS-POST

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2012
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.