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

NCT04933591 | Completed

• 1 other identifier: NIS-ВЕН-19.03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.)

  2 months

Study Arms (2)

study group

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

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/

Interventions

Diosmin / Hesperidin DRUG

Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms

Also known as: Venoactive drug

study group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

MeSH Terms

Conditions

Varicose Veins

Interventions

Diosmin; Hesperidin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavanones; Glycosides; Carbohydrates

Study Officials

• Igor Zolotukhin, PhD

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 22, 2021
• Study Start: September 1, 2020
• Primary Completion: August 28, 2021
• Study Completion: September 28, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)