Ruscus Evaluation for Symptom Control in Uncomplicated Chronic Venous Insufficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Venous Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Primary outcome measures
- Change in revised Venous Clinical Severity Score (rVCSS) [Time frame: Baseline, Day 30, and Day 90]
- Change in pain assessed by the Visual Analog Scale (VAS) [Time frame: Baseline, Day 30, and Day 90]
Secondary outcome measures (4)
- Change in Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score [Time frame: Baseline, Day 30, and Day 90]
- Change in CEAP clinical class [Time frame: Baseline, Day 30, and Day 90]
- Treatment adherence assessed by the Visual Analog Scale for Adherence (VAS-U) [Time frame: Day 30 and Day 90]
- Incidence of adverse events [Time frame: Baseline to Day 90]
Eligibility criteria
Inclusion criteria
- 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-C6.
- Willing and able to provide written informed consent and complete study as sessments.
Exclusion criteria
- Symptomatic patients classified as CEAP C0.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 25 centers
- Ankara Training and Research Hospital — Ankara
- Ankara University Faculty of Medicine Hospital — Ankara
- Bilkent City Hospital — Ankara
- Etlik City Hospital — Ankara
- Gazi University Faculty of Medicine Hospital — Ankara
- SBU Gulhane Training and Research Hospital — Ankara
- SBU Sincan Training and Research Hospital — Ankara
- Yıldırım Beyazıt University Yenimahalle Training and Research Hospital — Ankara
- … and 17 more centers
Identifiers
NCT: NCT07737236 · NEOVPS02