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

Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01741974

Acronym

PEARS

Enrollment

340

Registered

2012-12-05

Start date

2005-10-31

Completion date

2012-10-31

Last updated

2012-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Menopausal Syndrome

Keywords

perimenopause, phytoestrogen, atherosclerosis, intima-media thickness

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.

Interventions

DIETARY_SUPPLEMENTKarinat

DRUGPlacebo

Sugar pill manufactured to mimic Karinat 500 mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
B-mode ultrasound of carotid arteries	up to 3 years	Variation of intima-media thickness of common carotid arteries

Secondary

Measure	Time frame	Description
Measure of serum atherogenicity	up to 3 years	Change of the ability of serum to induce cholesterol accumulation in cultured cells

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026