Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01742000

Acronym

PEARS-POST

Enrollment

180

Registered

2012-12-05

Start date

2007-01-31

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

Keywords

postmenopause, phytoestrogen, atherosclerosis, intima-media thickness

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.

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

Healthy volunteers

Yes

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: 1. Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks 2. Pulmonary thromboembolism 3. Chronic heart failure IIa-III 4. Uncontrolled arterial hypertension (systolic blood pressure \> 145 mmHg, diastolic blood pressure \> 95 mmHg under hypotensive therapy) 5. Malignancy 6. Chronic renal failure II-III 7. Chronic hepatic failure II-III 8. Liver cirrhosis 9. Individual intolerance of Karinat or major side effects

Design outcomes

Primary

Measure	Time frame	Description
B-mode ultrasound of carotid arteries	up to 2 years	Variation of intima-media thickness of common carotid arteries

Secondary

Measure	Time frame	Description
Measure of serum atherogenicity	up to 2 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