Status:
COMPLETED
Clinical Trial to Assess the Efficacy of µSmin® Plus
Lead Sponsor:
Giellepi S.p.A
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Chronic Venous Disease
Eligibility:
All Genders
18-60 years
Phase:
NA
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 receivi...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2020
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04101201
Start Date
November 15 2019
End Date
April 24 2020
Last Update
June 25 2020
Active Locations (1)
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1
SCM Gados
Timișoara, Timiș County, Romania, 300425