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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741974
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Institute for Atherosclerosis Research, Russia

Tracking Information
First Submitted Date  ICMJE December 2, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE October 2005
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2012)
B-mode ultrasound of carotid arteries [ Time Frame: up to 3 years ]
Variation of intima-media thickness of common carotid arteries
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
Measure of serum atherogenicity [ Time Frame: up to 3 years ]
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Official Title  ICMJE Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Menopausal Syndrome
  • Atherosclerosis
Intervention  ICMJE
  • Dietary Supplement: Karinat
  • Drug: Placebo
    Sugar pill manufactured to mimic Karinat 500 mg tablet
Study Arms  ICMJE
  • Active Comparator: Karinat
    Karinat 500 mg tablet by mouth three times a day
    Intervention: Dietary Supplement: Karinat
  • Placebo Comparator: Sugar pill
    Placebo tablet 500 mg by mouth three times a day
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2012)
340
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741974
Other Study ID Numbers  ICMJE IAR-KT-PERI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute for Atherosclerosis Research, Russia
Study Sponsor  ICMJE Institute for Atherosclerosis Research, Russia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute for Atherosclerosis Research, Russia
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP