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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Active Comparator | 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 |
|
| control group | No Intervention | 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/ |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diosmin / Hesperidin | Drug | Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms |
|
| 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 |
| 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 |
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Inclusion Criteria:
• both female and male
Exclusion Criteria:
• age less than 18 and more than 50 years
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| Name | Affiliation | Role |
|---|---|---|
| Igor Zolotukhin, PhD | Pirogov Russian National Research Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pirogov Russian National Research Medical University | Moscow | 117997 | Russia |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004145 | Diosmin |
| D006569 | Hesperidin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D044950 | Flavanones |
| D006027 | Glycosides |
| D002241 | Carbohydrates |