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PEARS: Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women

Sponsor
Institute for Atherosclerosis Research, Russia (Other)
Overall Status
Completed
CT.gov ID
NCT01741974
Collaborator
(none)
340
Enrollment
2
Arms
84
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Karinat
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
340 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Karinat

Karinat 500 mg tablet by mouth three times a day

Dietary Supplement: Karinat
Placebo Comparator: Sugar pill

Placebo tablet 500 mg by mouth three times a day

Drug: Placebo
Sugar pill manufactured to mimic Karinat 500 mg tablet

Outcome Measures

Primary Outcome Measures

  1. B-mode ultrasound of carotid arteries [up to 3 years]

    Variation of intima-media thickness of common carotid arteries

Secondary Outcome Measures

  1. Measure of serum atherogenicity [up to 3 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Perimenopausal women aged 45 to 60 years with intact womb and ovaries

  • The absence of menstruations between 6 to 24 months

  • Last menstruation after the age of 40 years

  • Follicle-stimulating hormone (FSH) blood level ≥ 35 ng/ml

  • Mammography without nodal form of mastopathy or breast cancer signs

  • Absence of hypolipidemic therapy or HRT (hormone replacement therapy) during 6 months before the inclusion

Exclusion Criteria:

  • Administration of lipid-lowering drugs, and/or HRT, and/or phytoestrogens during 6 month before inclusion

  • Personal history or diagnostic of following diseases:

nodal form of mastopathy or breast cancer any cancer except non-melanoma skin cancer stroke or myocardial infarction chronic renal failure II-III chronic hepatic failure II-III liver cirrhosis chronic heart failure IIa-III exacerbation of chronic stomach or duodenal ulcer obesity (BMI >30 kg/m2) alcohol abuse uncontrolled arterial hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 90 mmHg) current cigarette smoking (>10 cigarettes a day) diabetes mellitus deep vein thrombosis or pulmonary embolism

  • Individual intolerance of Karinat or major side effects

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institute for Atherosclerosis Research, Russia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institute for Atherosclerosis Research, Russia
ClinicalTrials.gov Identifier:
NCT01741974
Other Study ID Numbers:
  • IAR-KT-PERI
First Posted:
Dec 5, 2012
Last Update Posted:
Dec 6, 2012
Last Verified:
Jan 1, 2012
Keywords provided by Institute for Atherosclerosis Research, Russia
perimenopause
phytoestrogen
atherosclerosis
intima-media thickness
Additional relevant MeSH terms:
Atherosclerosis

Study Results

No Results Posted as of Dec 6, 2012