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Идёт набор NCT07737236

Ruscus Evaluation for Symptom Control in Uncomplicated Chronic Venous Insufficiency

— Наблюдательное Chronic Venous Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Chronic Venous Disease. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Change in revised Venous Clinical Severity Score (rVCSS) [Срок оценки: Baseline, Day 30, and Day 90]
  • Change in pain assessed by the Visual Analog Scale (VAS) [Срок оценки: Baseline, Day 30, and Day 90]
Вторичные конечные точки (4)
  • Change in Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score [Срок оценки: Baseline, Day 30, and Day 90]
  • Change in CEAP clinical class [Срок оценки: Baseline, Day 30, and Day 90]
  • Treatment adherence assessed by the Visual Analog Scale for Adherence (VAS-U) [Срок оценки: Day 30 and Day 90]
  • Incidence of adverse events [Срок оценки: Baseline to Day 90]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 25 центров
  • 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
  • … и ещё 17 центров

Идентификаторы

NCT: NCT07737236 · NEOVPS02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗