A Clinical Multicenter, Phase III, Prospective, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 82
- 主要终点
- Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3
研究概览
简要总结
The objective is to evaluate the effectiveness of the safety of Daflon in decreasing symptoms resulting from chronic venous insufficiency when compared with Daflon.
详细描述
"A clinical multicenter, phase III, prospective, randomized, double-blind, comparative study to evaluate the efficacy and tolerability of Venaflon use in reducing the symptoms caused by chronic venous insufficiency when compared with Daflon."
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any ethnic group, both sexes and aged at least 18 years and a maximum of 65 years
- •Women and men of childbearing age who agree to use acceptable contraception throughout the study.
- •Be patient with chronic venous insufficiency of lower limbs varicose comDiagnostico clinical CEAP 0-3 by CEAP
- •Presence of at least 23 symptoms (pain, heaviness and discomfort, symptoms of heat and burning sensation in the legs) in the lower limbs, with a score equal to or greater than 4, as measured by visual analog scale
- •Being the 7 days without any medication or treatment related to the venous system.
- •Patients able to make proper use of medication
- •Patients who consent to participate in the study by signing the Instrument of Consent.
排除标准
- •Pregnant or breastfeeding women
- •Women who are breastfeeding
- •Women and men of childbearing age who do not accept to use acceptable contraception throughout the study
- •Patients under 18 or over 65 years
- •Patients with a history of hypersensitivity to any component of the formula
- •Presence of signs and symptoms of different conditions of venous disease to justify the pain or swelling
- •Use of elastic compression in the last two weeks
- •Venous obstruction of the lower limbs
- •Patients who have previously used or Venaflon Daflon and did not benefit;
- •Deep vein thrombosis in the last 6 months before entering the study;
- •Use of diuretics in the last 4 weeks
- •Previous venous surgery
- •Patients with renal and liver failure
- •Patients with gastritis or gastric ulcer
- •Patients with blood clotting disorders
- •Any condition which in the opinion of the physician researcher is significant and can make the patient unsuitable for study or you can place it under additional risk
研究组 & 干预措施
Venafon (Diosmin and Hesperidin)
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
干预措施: Daflon (Drug)
Daflon
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
干预措施: Venaflon (Diosmin and Hesperidin) (Drug)
结局指标
主要结局
Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3
时间窗: 30 days
To evaluate the efficacy of Venaflon compared with Daflon in the improves of symptomatic treatment of chronic venous insufficiency with classification CEAP 0-3
次要结局
- Identify adverse events, as well as their frequency and causality related to study medication.(30 days)