Clinical Trial to Assess the Efficacy of µSmin® Plus

Giellepi

Status: Completed

Conditions: Chronic Venous Disease

Treatments: Other: Placebo; Dietary Supplement: µSmin® Plus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04101201

CR2019/21

Details and patient eligibility

About

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

Full description

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

73 participants in 2 patient groups, including a placebo group

µSmin® Plus

Other group

Description:

µSmin® Plus is a new Micronized Diosmin Formulation for oral administration. Diosmin is extremely well tolerated and safe to use. Diosmin is safe for most people when used short-term for up to 6 months. During the 8 weeks of the clinical investigation, the subject will administer 1 tablet of µSMIN® Plus (corresponding to 450 mg of micronized diosmin) or placebo per day.

Treatment:

Dietary Supplement: µSmin® Plus

Placebo

Placebo Comparator group

Description:

It will be supplied by the Sponsor in an amount enough for the duration of the study. The subject will administer 1 tablet per day

Treatment:

Other: Placebo