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

Study Overview
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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.

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.

Official Title
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Impact of Treatment With VENARUS® on Vein-specific by Determining the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood

Conditions
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Varicose Veins

Intervention / Treatment
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* Drug: Diosmin / Hesperidin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>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 | Drug: Diosmin / Hesperidin<br>* Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms<br>* Other names: Venoactive drug;|
| No Intervention: control group<br>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/ | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein | Blood samples will be taken from varicose veins and level of cytokine Monocyte Chemoattractant Protein 1 will be measured by immunofluorescence. After 2 months measurement will be repeated and the change will be registered. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.) | Discomfort will be measured by visual-analogue scale. After 2 months measurement will be repeated and the change will be registered. | 2 months |