NCT02927483Unknown3 期
A Comparative Study to Assess the Efficacy and Safety of Endolex Forte vs Diosmin and Hesperidin in Reducing the symptomatoLogy of Patients With ChronIc VeNous Insufficiency Between Functional Classes CEAP 1-4, During a Period of 6 Months
SunWave Pharma0 个研究点目标入组 120 人开始时间: 2016年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 主要终点
- Change from baseline in limb volume determination at day 180 (water displacement method)
研究概览
简要总结
The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.
详细描述
A randomized, multicentered, open label, comparative study to assess the efficacy and safety of Endolex Forte® versus a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) in reducing the symptomatology of patients diagnosed with Chronic Venous Insufficiency which is rated between functional classes CEAP 1-4, during a period of 6 months.
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
- None
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
- •Patients, male or females aged 18 to 75 years old
- •Presence of chronic venous insufficiency which is rated between functional classes CEAP 1-4
- •Patients diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.or patients presenting a painful venous symptomatology in the lower limbs for at least 30 days.
- •Willing and able to give written informed consent prior to participation in the trial
- •Patients expected to be compliant with the study treatment
排除标准
- •Known allergy to the product's ingredients
- •Pregnancy or breastfeeding
- •Patient is involved in any other clinical trial
- •Deep vein thrombosis
- •Stasis dermatitis
- •The patient is taking non-steroids anti-inflammatory drugs include oral , topical creams or patch form)
- •Open ulcers or lower extremity amputation
- •Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion
- •Patient presenting permanent oedema,
- •Patient with a history of lower limbs trauma responsible for sequel pains
- •NYHA III and IV Heart Failure
- •Renal Failure
- •Untreated or uncontrolled Arterial Hypertension
- •Hepatic Failure
- •History of a known liver disease such as hepatitis A, hepatitis B, or C.
- •Malignant neoplasms, from any etiology, or who are receiving any type of anticancer treatment, unless when properly treated and with no evidence of recurrence during the last five years
- •Previous history of alcoholism, drug abuse, psychological or emotional problems in the last 5 years that can invalidate the Informed Consent Form or restrain participant's ability to comply with the requirements of the protocol.
- •Immobility.
结局指标
主要结局
Change from baseline in limb volume determination at day 180 (water displacement method)
时间窗: 180 days
次要结局
- Change from pre-treatment (baseline) in the calf circumference on treatment day 180(180 days)
- Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 180(180 days)
- Change from pre-treatment (baseline) in the calf circumference on treatment day 30(30 days)
- Global assessment of tolerability by the investigator at day 180(180 days)
- Change from baseline in limb volume determination at day 90 (water displacement method)(90 days)
- Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 90(90 days)
- Global assessment of efficacy by the investigator at day 180(180 days)
- Adverse events(180 days)
- Questionnaire on improvement in symptoms at day 180 (CIVIQ-20)(180 days)
研究者
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