NCT01110512Unknown3 期
Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Improvement of the parameters of CVI, such as edema of lower members.
研究概览
简要总结
It is hoped that with the use of medication, occurs improvement of the CVI parameters, such as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is non-inferior than the comparator.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who agree to the terms described in IC;
- •Subjects of both genders, aged ≥ 18 and ≤ 75 years with IVC framework of the lower limbs;
- •Subjects with CVI ranked 3 to 5, according to CEAP scale;
- •Patients complaining of pain and swelling in the lower limbs secondary to IVC;
- •Subjects with good mental health that can respond adequately to the study questionnaires;
- •Subjects who agree to make any return visits for evaluation;
排除标准
- •Patients with CVI classified as 0, 1, 2 or 6, according to CEAP;
- •Subjects who have received treatment for varicose veins as laser, medication use topical or oral (eg: brown India, coumarin, and etc.). And surgery in the 03 months preceding the study;
- •Patients with other diseases that may interfere with the study results: thrombosis, coagulation disorders and other diseases that the medical criteria, are important to be excluded;
- •Pregnant or nursing women;
- •Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
- •Participation in clinical trials in the twelve months preceding the study;
- •Patients with serious illnesses and uncontrolled that need multidrug treatment;
- •Patients on diuretics of any kind, regardless of pathology (hypertension, renal or liver disease);
- •Values of laboratory tests appropriate security; the Hemoglobin <10 mg / mL the creatinine> 1.5 mg / mL; AST, ALT, GGT ≥ 2 times normal values; the platelet count below 90.000/ml; Total Bilirubin and the fractions ≤ 1.5 times the normal range.
- •past medical history of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;
研究组 & 干预措施
Flavonid
Experimental
干预措施: Flavonid (Drug)
Daflon
Active Comparator
干预措施: Daflon (Drug)
结局指标
主要结局
Improvement of the parameters of CVI, such as edema of lower members.
时间窗: 90 days.
There will be 06 planned visits (V0, V1, V2, V3, V4 and V5).
次要结局
- Improvement of the parameters of CVI.(90 days)
研究者
研究点 (1)
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