The primary objective of the study is to evaluate, after 12 weeks (visit 3, V3), the effect of the combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe) on any changes in the total quality of life score, measured using the CIVIQ-20 (Chronic Venous Insufficiency Quality of Life Questionnaire), compared to baseline (visit 1, V1), in individuals with subjective symptoms in one or both lower limbs attributable to Chronic Venous Disease (CVD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
84
Although there is extensive clinical and pharmacological evidence regarding the activity of the individual components of the product, the specific effect of the fixed combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus as a single entity on quality of life in subjects with symptoms compatible with the early stages of Chronic Venous Disease (CVD) has not yet been explored.
AOU Policlinico Sant'Orsola Malpighi
Bologna, BO, Italy
NOT_YET_RECRUITINGUniversità degli Studi Magna Graecia
Catanzaro, CZ, Italy
NOT_YET_RECRUITINGIRCCS San Raffaele Pisana
Roma, Roma, Italy
RECRUITINGOspedale Policlinico Agostino Gemelli
Roma, Roma, Italy
NOT_YET_RECRUITINGAzienda ULSS7 Pademontana Regione Veneto
Bassano del Grappa, VI, Italy
NOT_YET_RECRUITINGVi.Gi. Centro Polispecialistico
Vibo Valentia, VV, Italy
RECRUITINGPrimary objective
The primary objective of the study is to evaluate after 12 weeks (visit 3, V3) the effect of the combination diosmin, hesperidin, bromelain and Ruscus aculeatus (Vesvein Legs) on any variations in the total quality of life score, measured using the questionnaire CIVIQ-20 (Chronic Venous Insufficiency Quality of Life Questionnaire) compared to baseline (visit 1, V1), in individuals with symptoms subjective to one or to both lower limbs and referable to Chronic Venous Disease (MVC).
Time frame: 12 weeks
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