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NCT Number: NCT07737236

Ruscus Evaluation for Symptom Control in Uncomplicated Chronic Venous Insufficiency

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Training and Research Hospital, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in revised Venous Clinical Severity Score (rVCSS)

    Time frame: 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

  2. Change in pain assessed by the Visual Analog Scale (VAS)

    Time frame: 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).

Secondary outcomes

  1. Change in Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score

    Time frame: Baseline, Day 30, and Day 90

    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.

  2. Change in CEAP clinical class

    Time frame: Baseline, Day 30, and Day 90

    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.

  3. Treatment adherence assessed by the Visual Analog Scale for Adherence (VAS-U)

    Time frame: Day 30 and Day 90

    Treatment adherence will be assessed using the Visual Analog Scale for Adherence (VAS-U) during routine follow-up visits.

  4. Incidence of adverse events

    Time frame: Baseline to Day 90

    Adverse events occurring during the observation period will be recorded and summarized according to severity, seriousness, and relationship to treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Nevzat Erdil, MD

CONTACT

[email protected]

+90 532 427 18 20

Sponsors and collaborators

Lead sponsor

Turkish Society for Vascular and Endovascular Surgery

Other

Registry information

Official study 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

Acronym: RESCUE-CVI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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