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

Sponsor
Pirogov Russian National Research Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04933591
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12.9
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Diosmin / Hesperidin
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Impact of Treatment With VENARUS® on Vein-specific by Determining the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Aug 28, 2021
Actual Study Completion Date :
Sep 28, 2021

Arms and Interventions

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/

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pirogov Russian National Research Medical University Moscow Russian Federation 117997

    Sponsors and Collaborators

    • Pirogov Russian National Research Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Igor Zolotukhin, Professor, Pirogov Russian National Research Medical University
    ClinicalTrials.gov Identifier:
    NCT04933591
    Other Study ID Numbers:
    • NIS-ВЕН-19.03
    First Posted:
    Jun 22, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Varicose Veins

    Study Results

    No Results Posted as of Mar 31, 2022