Back to resultsStudy of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women (PEARS-POST)
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Karinat
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis focused on measuring postmenopause, phytoestrogen, atherosclerosis, intima-media thickness
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Karinat
Sugar pill
Arm Description
Karinat 500 mg tablet by mouth three times a day
Placebo 500 mg tablet by mouth three times a day
Outcomes
Primary Outcome Measures
B-mode ultrasound of carotid arteries
Variation of intima-media thickness of common carotid arteries
Secondary Outcome Measures
Measure of serum atherogenicity
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Full Information
NCT ID
NCT01742000
First Posted
December 2, 2012
Last Updated
December 4, 2012
Sponsor
Institute for Atherosclerosis Research, Russia
1. Study Identification
Unique Protocol Identification Number
NCT01742000
Brief Title
Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
Acronym
PEARS-POST
Official Title
Double-blinded Placebo-controlled Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Atherosclerosis Research, Russia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
postmenopause, phytoestrogen, atherosclerosis, intima-media thickness
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Karinat
Arm Type
Active Comparator
Arm Description
Karinat 500 mg tablet by mouth three times a day
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo 500 mg tablet by mouth three times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Karinat
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill manufactured to mimic Karinat 500 mg tablet
Primary Outcome Measure Information:
Title
B-mode ultrasound of carotid arteries
Description
Variation of intima-media thickness of common carotid arteries
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Measure of serum atherogenicity
Description
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Time Frame
up to 2 years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
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