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.
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.
Study Type
OBSERVATIONAL
Enrollment
564
Ankara Training and Research Hospital
Ankara, Ankara, Turkey (Türkiye)
RECRUITINGAnkara University Faculty of Medicine Hospital
Ankara, Ankara, Turkey (Türkiye)
RECRUITINGBilkent City Hospital
Ankara, Ankara, Turkey (Türkiye)
RECRUITINGEtlik City Hospital
Ankara, Ankara, Turkey (Türkiye)
Change in revised Venous Clinical Severity Score (rVCSS)
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
Time frame: Baseline, Day 30, and Day 90
Change in pain assessed by the Visual Analog Scale (VAS)
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.
Time frame: Baseline, Day 30, and Day 90
Change in Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score
Change in quality of life from baseline to Day 30 and Day 90 assessed using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Higher scores indicate better quality of life.
Time frame: Baseline, Day 30, and Day 90
Change in CEAP clinical class
Change in CEAP clinical class from baseline to Day 30 and Day 90 will be recorded descriptively to evaluate the clinical course of chronic venous disease.
Time frame: Baseline, Day 30, and Day 90
Treatment adherence assessed by the Visual Analog Scale for Adherence (VAS-U)
Treatment adherence will be assessed using the Visual Analog Scale for Adherence (VAS-U), a self-reported 100-mm visual analog scale ranging from 0 to 100 mm. A score of 0 mm indicates "never" taking the medication as prescribed, and a score of 100 mm indicates "always" taking the medication as prescribed. Higher scores indicate better treatment adherence.
Time frame: Day 30 and Day 90
Incidence of adverse events
Adverse events occurring during the observation period will be recorded and summarized according to severity, seriousness, and relationship to treatment.
Time frame: Baseline to Day 90
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