search
Back to results

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

Primary Purpose

Varicose Veins

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Diosmin / Hesperidin
Sponsored by
Pirogov Russian National Research Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Varicose Veins

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Pirogov Russian National Research Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

study group

control group

Arm 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

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/

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 7, 2021
Last Updated
March 29, 2022
Sponsor
Pirogov Russian National Research Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04933591
Brief Title
Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
Official Title
Impact of Treatment With VENARUS® on Vein-specific by Determining the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 28, 2021 (Actual)
Study Completion Date
September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pirogov Russian National Research Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Active Comparator
Arm 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
Arm Title
control group
Arm Type
No Intervention
Arm 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/
Intervention Type
Drug
Intervention Name(s)
Diosmin / Hesperidin
Other Intervention Name(s)
Venoactive drug
Intervention Description
Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms
Primary Outcome Measure Information:
Title
Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.)
Description
Discomfort will be measured by visual-analogue scale. After 2 months measurement will be repeated and the change will be registered.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Zolotukhin, PhD
Organizational Affiliation
Pirogov Russian National Research Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pirogov Russian National Research Medical University
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs