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

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

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Drug: Diosmin / Hesperidin

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 117997
    • Pirogov Russian National Research Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Diosmin / Hesperidin; Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms; Other Names: Venoactive drug
No Intervention: 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/

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Investigators: Principal Investigator: Igor Zolotukhin, PhD, Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): August 28, 2021
• Study Completion (Actual): September 28, 2021

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 13, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: NIS-ВЕН-19.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No