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

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.

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.