Effects of One Dietary Supplement Tablet of VESVEIN on the Quality of Life in Lower-limb Disorders
NCT07919132, Not applicable, Completed, IRCCS San Raffaele Roma
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of One Dietary Supplement Tablet of VESVEIN on the Quality of Life in Lower-limb Disorders | ClinicalTrials.gov |
| NCT number | NCT07919132 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 31 participants, actual | ClinicalTrials.gov |
| Lead sponsor | IRCCS San Raffaele Roma | ClinicalTrials.gov |
| Conditions | Chronic Venous Disease of Lower Limbs | ClinicalTrials.gov |
| Interventions | Fixed combination of diosmin (450 mg), Hesperidin (50 mg), bromelain (75 mg, 2500 GDU/g), ananas comosus (5 mg), Ruscus 37.5 mg | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20) total score | From inclusion to 12 weeks (± 3 days) | Changes in the Chronic Venous Insufficiency Quality of Life (CIVIQ-20) total score at V3, after 12 weeks (± 3 days) of supplementation, compared to baseline (V1 inclusion). Changes in the CIVIQ-20 score were considered clinically significant for a reduction of at least 5 points from baseline The CIVIQ-20 is a self-administered instrument validated in several languages, in-cluding Italian, to assess quality of life in CVD. The total score is the sum of the 20 items and ranges from 20 to 100, with higher scores indicating poorer QoL | ClinicalTrials.gov |
| Secondary | Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20) total score | From inclusion to 4 weeks (± 3 days) of supplementation | Changes in the Chronic Venous Insufficiency Quality of Life (CIVIQ-20) total score at V2, after 4 weeks (± 3 days) of supplementation compared to baseline. The CIVIQ-20 is a self-administered instrument validated in several languages, in-cluding Italian, to assess quality of life in CVD. The total score is the sum of the 20 items and ranges from 20 to 100, with higher scores indicating poorer QoL | ClinicalTrials.gov |
| Secondary | Chronic Venous Disease related symptoms | From inclusion to 4 and 12 weeks (± 3 days) of supplementation | Number and Severity of subjective chronic venous disease related symptoms (sensation of heavy/swollen/tender legs, cramps at night, sensation of heavy/tired legs, itching skin, burning/warmth, tingling, lower limb restlessness) perceived by the individual included in the study assessed at V2 and V3 (after 4 and 12 weeks (± 3 days) from inclusion. Changes in each symptom are recorded by the Investigators and classified as improvement (mild, moderate, or disappearance) or worsening. | ClinicalTrials.gov |
| Secondary | Visual analogue scale (VAS) score | From inclusion to 4, 12 and 16 weeks (± 3 days) | Symptoms burden perceived by the individual included in the study recorded using a 100-point Visual Analogue Scale (VAS) and evaluated after 4 and 12 weeks (± 3 days) of supplementation and at Visit 4, after 4 weeks from the end of supplementation compared to inclusion. The Visual analogue scale (VAS) is a simple, generic and non-disease-specific tool that provides a quick summary measure of how participants perceive the severity of their symptoms thus affecting quality of life. The VAS consisted of a 100-mm line, presented vertically, anchored at one end by 0 and at the other by 100. Subjects mark the point on the line that best represents the in-tensity of their symptoms and write the corresponding value in a dedicated space. A higher VAS score correlates with a more severe negative impact of symptoms on quality of life. | ClinicalTrials.gov |
| Secondary | Venous disability score (VDS) | From inclusion to 4, 12 and 16 weeks (± 3 days) | Overall impact of chronic venous disease clinical symptoms on daily life activities using the venous disability score (VDS) after 4, 12 and 16 weeks (± 3 days) compared to inclusion. The VDS is a short tool designed to assess the overall impact of venous symptoms on daily activities, using a 4-point scale: 0 = asymptomatic; 1 = symptomatic, able to carry out usual activities without compression therapy; 2 = able to carry out usual activities only with compression and/or limb elevation and 3 = unable to carry out usual ac-tivities even with compression and/or limb elevation. A higher VDS score correlates with a more severe impairment of daily activities due to CVD-related symptoms | ClinicalTrials.gov |
| Secondary | Adherence | From inclusion to 4 and 12 weeks (± 3 days) | Adherence to the correct intake of the study supplementation, measured after 4 and 12 weeks (± 3 days) of supplementation by counting the dosing units actually taken and the number of doses theoretically required for the treatment period, expressed as a percentage ratio. For example, for a recommended intake of 80 days at 2 tablets per day, 160 doses were required; if 160 doses were taken, adherence was 100%; if 80 doses were taken, adherence was 50% (80/160 × 100). Adherence is considered acceptable if intake of the study product was ≥ 80% of the theoretical amount. | ClinicalTrials.gov |
| Secondary | Incidence of side effects and or adverse events (safety and tolerability) | From the signing of the informed consent to the end of the supplementation | Side effects and Adverse events (AEs) experienced by the individual included in the study will be recorded from inclusion and during the duration of the study. A full description including onset, type of any side effects and/or adverse events, intensity and course will be recorded. AEs with a potential correlation with the study product, and any serious adverse event (SAEs) or AEs leading to early study discontinuation will be identified and recorded. | ClinicalTrials.gov |
| Secondary | Chronic Venous Insufficiency Quality of Life (CIVIQ-20) global index score (GIS) | From inclusion to 4 and 12 weeks | Changes in the Chronic Venous Insufficiency Quality of Life (CIVIQ-20) global index score (GIS) after 4 and 12 weeks (± 3 days) of supplementation compared to baseline. The CIVIQ-20 is a self-administered instrument validated in several languages, in-cluding Italian, to assess quality of life in CVD. This endpoint is considered met if the score decreased by at least 6 points from baseline at each time point. The Global Index Score (GIS) is calculated as the difference between the final score and the lowest possible score of the CIVIQ-20, divided by the theoretical score range (80), and multiplied by 100, as follows: GIS = \[(total score - 20) / (100 - 20)\] × 100 The GIS ranges from 0 to 100 and, like the total score, is inversely related to QoL. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)