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

Not Applicable

Completed

• Conditions: Varicose Veins
• Interventions: Drug: Diosmin / Hesperidin

• Registration Number: NCT04933591
• Lead Sponsor: Pirogov Russian National Research Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-13
• Study First Posted: 2021-06-22
• Primary Completion: 2021-08-28
• Study Completion: 2021-09-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Diosmin / Hesperidin	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

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein	2 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pirogov Russian National Research Medical University; 🇷🇺 Moscow, Russian Federation