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

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)

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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/