NCT01956318已完成3 期
Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency. A Randomized Clinical Trial.
Centre de Recherche Rhumatologique et Thermal0 个研究点目标入组 99 人开始时间: 2010年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 主要终点
- number of patient with 20% improvement of CIVIC scale at 3 months
研究概览
简要总结
At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic venous insufficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18 to 80 years with chronic venous insufficiency regardless of etiology stages 3 or 4 according to the CEAP classification (Clinical severity, Etiology or cause, Anatomy, Pathophysiology)
- •Patients available to participate in a 3 weeks session in the spa center and to be followed for 6 months
排除标准
- •pregnant women,
- •contra-indication for the spa treatment (chronic infectious diseases, cancer, heart failure, serious liver or kidney disease, open leg ulcer, psychiatric disorders, immune deficiency, phlebitis, erysipelas or history of erysipelas);
- •surgery in the next three months,
- •spa treatment in the previous 6 months,
- •professional involvement with a spa resort
结局指标
主要结局
number of patient with 20% improvement of CIVIC scale at 3 months
时间窗: 3 months
Primary outcome is the number of patient with 20% improvement in quality of life (CIVIC scale) at 3 months
次要结局
- CIVIC(1 month)
- civic(1 & 3 months)
- Rutherford severity score(1 & 3 months)
- PASS(1 & 3 months)
- opinion of patient and practitionner(1 & 3 months)
- associated treatment(1 & 3 months)
- side effects(week 1 & 3. 1 & 3 months)
研究者
FORESTIER Romain
President of the research center
Centre de Recherche Rhumatologique et Thermal
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