Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of µSmin® Plus (Dietary Supplement) in Chronic Venous Insufficiency Symptoms Relief
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Quality of life assessed
研究概览
简要总结
This study evaluates treatment with the dietary supplement µSmin® Plus in a group of patients suffering from chronic venous insufficiency in comparison with a similarly-sized group of patients receiving placebo evaluated by quality of life questionnaires, VAS pain scale, CVI symptomatology, and change in the circumference of the affected leg at calf level
详细描述
In this study we use a dietary supplement - µSmin® Plus - for symptomatic treatment of CVI and we will monitor its impact on CVI symptoms, features, and consequences (item) of the disease listed below: limb edema, walking, daily tasks performance, pain/burning symptoms, pruritus/paresthesis, sensation of heaviness/fatigue, time wasted in the management of the disease, social burden, disease impact on self-confidence, and its impact on physical exercise/recreational activities. Results of related clinical trials were published before showing that this is an active field in clinical reasearch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with age ≥18 and ≤60 with chronic venous insufficiency;
- •The chronic venous insufficiency must be graded between C2-C4 on the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system;
- •Able to communicate adequately with the investigator and to comply with the requirements for the entire study;
- •Capable of and freely willing to provide written informed consent prior to participating in the study;
- •Light smokers (<10 cigarettes per day).
排除标准
- •Patients suffering from other or associated vascular diseases, diabetes or bleeding disorders;
- •Oedema of the lower limbs of cardiac, renal or hepatic origin;
- •Presence of symptoms and/or trophic disorders of arterial, metabolic, neurological or orthopedic origin including traumas, arthritis, neuropathy;
- •One or more factors likely to affect venous symptoms such as recent childbirth, recent stripping, or deep or superficial venous thrombosis of the lower limbs during the previous 6 months;
- •Obese subjects (BMI > 30);
- •Hypersensitivity to active principles contained in the tested food supplement (diosmin);
- •Patients considered smokers (≥10 cigarettes/day);
- •Patients with concomitant or history of addiction to alcohol, spices or drug abuse;
- •Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception;
- •Participation in an interventional clinical study in the previous 30 days;
- •Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.
结局指标
主要结局
Quality of life assessed
时间窗: 56 days
Quality of life is assessed by ChronIc Venous Insuficiency quality of life Questionnaire ( CIVIQ-20 questionnaire ). The 20-item questionnaire, provides a global index and an outline of 4 quality-of-life dimensions-"pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). Items on the CIVIQ-20 scale were scored from 1 to 5. There are 20 questions in the CIVIQ-20, each with 5 possible answers (1 to 5), the minimum possible score being 20 and the maximum 100. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (100-20=80), multiplied by 100. A low score will correspond to greater patient comfort.
Change in the circumference of each affected leg
时间窗: 56 days
To evaluate the efficacy of the dietary supplement µSmin® Plus on ameliorating the symptoms of Chronic Venous Insufficiency in terms of change in the circumference of affected legs and quality of life, in comparison with placebo, from baseline to week 8 visit; The unit for this measurement is centimeter.
次要结局
- Investigator Global Assessment of Safety (IGAS):(56 days)
- Percentage of subjects who would want to continue with µSmin® Plus.(56 days)
- Symptoms relief assessed by Venous Clinical Severity Score (VCSS) questionnaire(56 days)
- Visual Analogue Scale ( VAS scale ) from 0 to 10 for pain measurements(56 days)
- Investigator Global Assessment of the efficacy by scoresproduct(56 days)
- Patient Global Assessment of the efficacy by scores(56 days)
- Percentage of subjects who experienced symptoms relief(56 days)
- Treatment compliance(56 days)
- AE/SAE incidence(56 days)