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Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood

P

Pirogov Russian National Research Medical University

Status

Completed

Conditions

Varicose Veins

Treatments

Drug: Diosmin / Hesperidin

Study type

Interventional

Funder types

Other

Identifiers

NCT04933591
NIS-ВЕН-19.03

Details and patient eligibility

About

This study is designed to find if the venoactive drug contained diosmin and hesperidin is able to work against chronic vein-specific inflammation by changing the level of Monocyte Chemoattractant Protein 1. This chemokine is involved in the vein wall remodeling in patients with lower limb varicose veins.

Full description

The study is a post-registration open-label observational prospective single-center study with minimal intervention. Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr will be invited to participate in the study.

Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Blood will be drawn from the varicose vein of the affected limb. Discomfort in the affected limb will be evaluated by a visual-analog scale. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.

Enrollment

30 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • • both female and male

    • age from 18 to 50 years old
    • Verified diagnosis of chronic venous insufficiency CEAP C2-C4
    • signed infromed consent
    • Absence of any other treatment 2 weeks before the start of the study and throughout the duration of the study

Exclusion criteria

  • • age less than 18 and more than 50 years

    • Previously performed invasive interventions for varicose veins on any of the lower extremities
    • No visible varicose veins
    • Thrombophlebitis and deep vein thrombosis of the lower extremities in the past
    • Taking prohibited pre-trial therapy
    • Contraindications to taking Venarus®
    • not signed informed consent

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

study group
Active Comparator group
Description:
Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr. Clinical and ultrasound examinations will be used to confirm varicose veins disease. It is planned to take blood samples from a varicose vein before and after administration of Venarus® (100 mg hesperidin + 900 mg diosmin) for 2 months
Treatment:
Drug: Diosmin / Hesperidin
control group
No Intervention group
Description:
Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr vein. Clinical and ultrasound examinations will be used to confirm varicose veins disease. It is planned to take blood samples from a varicose vein at inclusion and 2 months later/

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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