Clinical Study of Non-inferiority Between Aesculus Hippocastanum 50mg, Polygonum Acre 10mg, Smilax Pepyracea 40mg, Rutin 20mg Versus Diosmin 450mg and Hesperidin 50mg Tablets in Chronic Venous Insufficiency After 3 Months of Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- visual analogic scale
研究概览
简要总结
To demonstrate the clinical non-inferiority of efficacy between Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, Rutin and Diosmin 450mg and Hesperidin 50mg tablets in the improvement of lower limb symptoms assessed by means of a 100mm visual scale (VAS) over 3 months among adult patients presenting with chronic venous insufficiency of the lower limbs.
详细描述
Phlebotonics represent a heterogeneous group of therapeutic products of natural or synthetic origin that exhibit effects on edema and/or symptoms related to chronic venous diseaseThis class of drugs is effective in improving the symptoms of chronic venous insufficiency and in cases of hemorrhoids and for this reason they have become an established component of the therapeutic arsenal for all phases of these diseases Phlebotomics are classified into four categories: benzopyrones, saponins, other plant extracts, and synthetic drugs
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
coated tablets
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting CEAP classification from grade C0 to C3 in the evaluation of venous disease of the lower limbs
- •Clinical symptoms of chronic venous insufficiency of the lower limbs, defined by the 100mm visual scale performed by the patient between 20mm and 60mm in the most symptomatic lower limb.
- •For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraceptives.
- •Patient read, understood, signed and dated the free and informed consent form
排除标准
- •Treatment with compression stockings within 2 months of study inclusion date
- •Treatment with venotonics within 2 months of the date of inclusion in the study
- •Women of reproductive age who are pregnant or breastfeeding, or who do not wish to use contraception during the study period.
- •Known allergy or hypersensitivity to any component of the study drug
- •Known significant laboratory abnormality
- •CEAP Grade Assessment of level 4, 5, or
- •Patient with venous disease requiring intravenous chemical surgery/sclerotherapy
- •Patient presenting with a painful pathology in addition to venous pain in the lower limbs
- •Patient with a history of thrombosis or thromboembolic disease within 6 months of the date of inclusion in the study
- •10. Patient with a change in general condition that is incompatible with his/her participation in the study
- •Patient who wishes to become pregnant within 6 months
研究组 & 干预措施
Diosmina, and Hesperidina
Diosmina 450mg e Hesperidina 50mg
干预措施: Aesculus hippocastanum, and associations (Drug)
Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and Rutina
Aesculus hippocastanum 50mg, Polygonum acre 10mg, Smilax Pepyracea 40mg, Rutina 20mg
干预措施: Aesculus hippocastanum, and associations (Drug)
结局指标
主要结局
visual analogic scale
时间窗: 3 months
A 100 mm VAS (visual analogic scale) is marked from 0 (absence of venous symptoms) up to 100 (maximum symptomatic venous manifestations) by the patient (higher scores means a worse outcome). It is fulfilled by the patient him- or herself, under the physician's watch. VAS is meant to globally evaluate lower limbs venous symptomatology (heavy legs, painful legs, fatigued legs, deambulation limitations, swollen sensation and/or lower limbs tension).
次要结局
- Quality of life as measured by a specific chronic venous insufficiency questionnaire(3 months)
- Oral acceptability by the patient through the use of a visual analogic scale(3 months)
- Patient's satisfaction to study medications(3 months)
- Physician's satisfaction to study medications(3 months)
- Medical tolerability to tested drugs as measured by the investigator(3 months)
研究者
Carlos Pereira Nunes
Professor
Fundação Educacional Serra dos Órgãos