CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
µSmin® Plus +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04101201
NCT04101201N/ACompleted

Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of µSmin® Plus (Dietary Supplement) in Chronic Venous Insufficiency Symptoms Relief

Giellepi S.p.A·interventional·Posted Sep 24, 2019·Updated Jun 25, 2020

In Brief

A clinical study evaluating µSmin® Plus and Placebo for Chronic Venous Disease. Completed, enrolled 73 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRomania

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 24, 2019
Enrollment StartNov 15, 2019
Primary CompletionApr 24, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.8 years ago

Interventions

µSmin® Plusdietary

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.

Placeboother

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