An interventional study of Fixed combination of diosmin (450 mg), Hesperidin (50 mg), bromelain (75 mg, 2500 GDU/g), ananas comosus (5 mg), Ruscus 37.5 mg in Chronic Venous Disease of Lower Limbs, sponsored by IRCCS San Raffaele Roma. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by IRCCS San Raffaele Roma · Not applicable, Interventional, and Supportive care
The purpose of this trial is to evaluate the effects of a single tablet of a new fixed combination of food supplement containing Ruscus, diosmin, hesperidin, ananas comosus, bromelain administered for 12 weeks on quality of life measured with the Chronic Venous Insufficiency Quality of Life questionnaire (CIVIQ-20) in individuals with symptoms possibly related to the onset of chronic venous disease.
The purpose of this trial is to evaluate in 31 participants with symptoms possibly related to the onset of chronic venous disease, the effects of a single tablet of a new fixed combination of food supplement containing Ruscus, diosmin, hesperidin, ananas comosus, bromelain on quality of life, changes of symptoms burden and impact of symptoms on daily activities after 4 and 12 weeks.
IRCCS San Raffaele Roma is the lead sponsor of 71 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
subjects with chronic venous disease (CVD)-related symptoms receiving at inclusion the study supplementation (a combination of diosmin, hesperidin, bromelin, ananas comosus and Ruscus aculeatus)
Dietary Supplement: Fixed combination of diosmin (450 mg), Hesperidin (50 mg), bromelain (75 mg, 2500 GDU/g), ananas comosus (5 mg), Ruscus 37.5 mg
The dietary supplement is given obce dailty with meal
Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20) total score
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
Time frame: From inclusion to 12 weeks (± 3 days)
Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20) total score
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
Time frame: From inclusion to 4 weeks (± 3 days) of supplementation
Chronic Venous Disease related symptoms
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.
Time frame: From inclusion to 4 and 12 weeks (± 3 days) of supplementation
Visual analogue scale (VAS) score
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.
Time frame: From inclusion to 4, 12 and 16 weeks (± 3 days)
Venous disability score (VDS)
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
Time frame: From inclusion to 4, 12 and 16 weeks (± 3 days)
Adherence
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.
Time frame: From inclusion to 4 and 12 weeks (± 3 days)
Incidence of side effects and or adverse events (safety and tolerability)
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.
Time frame: From the signing of the informed consent to the end of the supplementation
Chronic Venous Insufficiency Quality of Life (CIVIQ-20) global index score (GIS)
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.
Time frame: From inclusion to 4 and 12 weeks
Plan to share: No — There is no need or intention to share individual data of participants.
Ran from Jun 2026 to primary completion in Sep 2026, 3 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele Roma