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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-09-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Varicose Veins

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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study group

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

Group Type ACTIVE_COMPARATOR

Diosmin / Hesperidin

Intervention Type DRUG

Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms

control group

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/

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diosmin / Hesperidin

Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms

Intervention Type DRUG

Other Intervention Names

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Venoactive drug

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No