Clinical trial NCT04101201: Clinical Trial to Assess the Efficacy of µSmin® Plus
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of µSmin® Plus (Dietary Supplement) in Chronic Venous Insufficiency Symptoms Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Disease
Lead sponsor: Giellepi S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2019-09-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Diosmin is a naturally occurring flavonoid present in citrus fruits and other plants belonging to the Rutaceae family. It is used for the treatment of chronic venous insufficiency (CVI) for its pheblotonic and vaso-active properties, safety and tolerability as well.

µSmin® Plus is a proprietary flavonoid complex with enhanced bio-efficacy. It contains highly concentrated micronized and standardized Diosmin. Highly improved bioavailability and improved oral absorption by micronization of the particles.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life assessed
timeFrame: 56 days
measure: Change in the circumference of each affected leg
timeFrame: 56 days
Secondary outcomes:
measure: Visual Analogue Scale ( VAS scale ) from 0 to 10 for pain measurements
timeFrame: 56 days
measure: Symptoms relief assessed by Venous Clinical Severity Score (VCSS) questionnaire
timeFrame: 56 days
measure: Investigator Global Assessment of the efficacy by scoresproduct
timeFrame: 56 days
measure: Patient Global Assessment of the efficacy by scores
timeFrame: 56 days
measure: Percentage of subjects who would want to continue with µSmin® Plus.
timeFrame: 56 days
measure: Percentage of subjects who experienced symptoms relief
timeFrame: 56 days
measure: Treatment compliance
timeFrame: 56 days
measure: AE/SAE incidence
timeFrame: 56 days
measure: Investigator Global Assessment of Safety (IGAS):
timeFrame: 56 days
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: SCM Gados
state: Timis
Study officials:
affiliation: SCM Dr. Rosu
name: Doina Rosu, MD
role: PRINCIPAL_INVESTIGATOR
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