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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VESVEIN | Experimental | VESVEIN Gambe, (Ekalab S.r.l., Italia) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary 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 range 20-100 higher scores mean a worse outcome) 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). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico Sant'Orsola Malpighi | Bologna | BO | 40138 | Italy | ||
| Università degli Studi Magna Graecia |
no IPD sharing foreseen
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|
| Catanzaro |
| CZ |
| 88100 |
| Italy |
| IRCCS San Raffaele Pisana | Roma | Roma | 00163 | Italy |
| Vi.Gi. Centro Polispecialistico | Vibo Valentia | VV | 89900 | Italy |
| ID | Term |
|---|---|
| D006569 | Hesperidin |
| D001963 | Bromelains |
| ID | Term |
|---|---|
| D044950 | Flavanones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003546 | Cysteine Endopeptidases |
| D057056 | Cysteine Proteases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010450 | Endopeptidases |
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