Impact of Treatment With VENARUS® on Vein-specific by Determining the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •• 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
研究组 & 干预措施
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
干预措施: Diosmin / Hesperidin (Drug)
结局指标
主要结局
Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein
时间窗: 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.
次要结局
- Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.)(2 months)
研究者
Igor Zolotukhin
Professor
Pirogov Russian National Research Medical University