Evaluation of the Effects of Ruscus Aculeatus L. on Clinical Course and Quality of Life, and Assessment of Treatment Adherence and Tolerability in the Treatment of Chronic Venous Insufficiency: A Multicenter, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 564
- 试验地点
- 25
- 主要终点
- Change in revised Venous Clinical Severity Score (rVCSS)
研究概览
简要总结
This multicenter, prospective, observational study aims to generate and analyze real-world data on the effectiveness and safety of Ruscus aculeatus L. treatment in patients with symptomatic chronic venous disease classified as CEAP C1-C6. Patients receiving Ruscus aculeatus L. as part of routine clinical practice will be followed for 90 days without any study-mandated intervention. Disease severity will be assessed using the revised Venous Clinical Severity Score (rVCSS), pain using the Visual Analog Scale (VAS), quality of life using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), treatment adherence using the Visual Analog Scale for adherence (VAS-U), and safety through the collection of adverse events during the observation period.
详细描述
Chronic venous disease (CVD) is a common condition associated with considerable morbidity and reduced quality of life. Ruscus aculeatus L. has been used as a venoactive agent for the symptomatic treatment of chronic venous disease; however, real-world clinical data on the use of Ruscus aculeatus L. alone remain limited.
This multicenter, prospective, observational study is designed to generate real-world evidence on the effectiveness, safety, treatment adherence, and quality of life associated with Ruscus aculeatus L. treatment in patients with symptomatic chronic venous disease classified as CEAP C1-C6. Patients who are prescribed Ruscus aculeatus L. as part of routine clinical practice will be followed for approximately 90 days without any study-specific intervention. Treatment decisions, diagnostic procedures, and patient management will remain entirely at the discretion of the treating physician.
Clinical outcomes will be evaluated using the revised Venous Clinical Severity Score (rVCSS), pain assessed by the Visual Analog Scale (VAS), quality of life assessed by the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), treatment adherence assessed by the Visual Analog Scale for adherence (VAS-U), and safety assessed through the collection of adverse events during routine follow-up visits. Data will be collected during routine clinical visits at baseline, Day 30, and Day 90.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years.
- •Patients prescribed Ruscus aculeatus L. as part of routine clinical practice, with the baseline visit performed within 7 days after treatment initiation.
- •Symptomatic chronic venous disease classified as CEAP (2020) C1-C
- •Willing and able to provide written informed consent and complete study as sessments.
排除标准
- •Symptomatic patients classified as CEAP C
- •Uncontrolled hypertension.
- •Lower extremity dermatitis or ulcer related to peripheral arterial disease or diabetes.
- •Neurological or orthopedic conditions limiting mobility or independent walking.
- •Active systemic infection.
- •Known malignancy or ongoing chemotherapy.
- •Acute deep vein thrombosis or acute superficial vein thrombosis.
- •Cognitive or physical conditions preventing participation in routine follow-up visits.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Patients with Symptomatic Chronic Venous Disease Receiving Ruscus aculeatus L.
Adults with symptomatic chronic venous disease (CEAP C1-C6) who are prescribed Ruscus aculeatus L. as part of routine clinical practice. Participants will be followed prospectively for approximately 90 days without any study-specific intervention. Clinical outcomes, treatment adherence, quality of life, and safety data will be collected during routine clinical visits at baseline, Day 30, and Day 90.
结局指标
主要结局
Change in revised Venous Clinical Severity Score (rVCSS)
时间窗: Baseline, Day 30, and Day 90
Change in disease severity from baseline to Day 30 and Day 90 assessed using the revised Venous Clinical Severity Score (rVCSS). Higher scores indicate greater disease severity
Change in pain assessed by the Visual Analog Scale (VAS)
时间窗: Baseline, Day 30, and Day 90
Change in pain severity at rest and during exercise from baseline to Day 30 and Day 90 assessed using the Visual Analog Scale (VAS), scored from 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity.
次要结局
- Change in Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score(Baseline, Day 30, and Day 90)
- Change in CEAP clinical class(Baseline, Day 30, and Day 90)
- Incidence of adverse events(Baseline to Day 90)
- Treatment adherence assessed by the Visual Analog Scale for Adherence (VAS-U)(Day 30 and Day 90)