Dietary supplement of diosmin, hesperidin, bromelain and Ruscus for early leg vein symptoms

Effects of a Dietary Supplement Composed of Diosmin, Hesperidin, Bromelain, and Ruscus Aculeatus on the Quality of Life in Subjects With Lower Limb Disorders Possibly Prodromal to Chronic Venous Disease

This trial will test whether a daily supplement containing diosmin, hesperidin, bromelain, and Ruscus aculeatus improves quality of life for adults with early symptoms of chronic venous disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ekalab S.r.l. (Industry-sponsored)
• Locations: 6 sites (Bologna, BO and 5 other locations)
• Trial ID: NCT07185386 on ClinicalTrials.gov

What this trial studies

This interventional, multicenter 12-week protocol gives adults with subjective lower-limb symptoms an oral supplement (Vesvein Gambe) containing diosmin, hesperidin, bromelain, and Ruscus aculeatus and compares quality of life at baseline and week 12 using the CIVIQ-20 questionnaire. The primary endpoint is the change in total CIVIQ-20 score from visit 1 (baseline) to visit 3 (12 weeks). Eligible participants are adults aged 18 or older with at least one symptom possibly related to chronic venous disease and who provide informed consent, while pregnant or breastfeeding women and those not using adequate contraception are excluded. The trial is being run at three Italian clinical sites and appears to be a before-and-after (baseline vs 12 weeks) intervention without a listed comparator arm.

Who should consider this trial

Good fit: Adults aged 18 or older who have at least one subjective lower-limb symptom possibly due to chronic venous disease (for example heaviness, swelling, pain, cramps, itching, burning, or tingling) and who can attend the study visits are suited for this protocol.

Not a fit: Individuals with advanced, clinically confirmed chronic venous disease, leg symptoms primarily from non-venous causes, pregnant or breastfeeding women, or those unwilling to use required contraception are unlikely to benefit from this specific intervention.

Why it matters

Potential benefit: If effective, the supplement could reduce leg symptoms and improve daily quality of life for people with early chronic venous disease.

How similar studies have performed: Previous research on venoactive agents such as diosmin/hesperidin and Ruscus extracts has shown symptom and quality-of-life benefits, though evidence for this exact combination and formulation is more limited.

Eligibility criteria

Inclusion Criteria:

* Both sexes;
* Age ≥18 years;
* Signed informed consent form for participation in the study;
* Presence of at least one clinical symptom possibly related to chronic venous disease (such as heaviness and/or swelling and/or pain in the lower limbs, nighttime cramps, tired/heavy legs, itching, burning and/or warmth, tingling, or restlessness in the lower limbs);
* Willingness to participate in the study and to comply with the study procedures, as confirmed by signing the written informed consent.

Exclusion Criteria:

Pregnancy or current breastfeeding; Women of childbearing potential who are not using adequate birth control methods (either hormonal contraception in the form of contraceptive pills, or barrier birth control methods used in combination with a spermicidal product such as foam, gel, or film).

\[For the entire duration of the study, women of childbearing potential-defined as those who are less than one year post-menopause or who have not undergone hysterectomy or tubal ligation-must use an effective method of contraception, in accordance with Note 3 of the ICH M3 Guideline. A contraceptive method is considered highly effective if it results in a failure rate of less than 1% per year. Effective contraceptive methods include: hormonal contraceptives containing estrogens and progestins (oral, intravaginal, transdermal) that inhibit ovulation; hormonal contraceptives containing progestins only (oral, injectable, implantable); intrauterine devices (IUDs); hormone-releasing intrauterine systems (IUS); partner vasectomy; sexual abstinence\]; Individuals with chronic venous insufficiency classified as CEAP stages C3-C6 (see Annex 1); Individuals with a positive pitting edema sign detected at Visit 1 after signing the informed consent; Patients with documented deep vein thrombosis within the last 6 months; Current or recent (within the last 4 weeks) use of venoactive and/or anti-edematous products; Individuals scheduled for surgical procedures within 3 months of enrollment; Subjects with a history of heart failure (NYHA Class III-IV), chronic kidney disease, and/or severe hepatic insufficiency; Ongoing oncological or immunosuppressive diseases; Celiac disease; Drug and/or alcohol abuse; Neurological or psychiatric disorders that may impair the validity of informed consent and/or compromise adherence to the study procedures; Known allergy, hypersensitivity, or intolerance to any component of the investigational dietary supplement; Any medical or non-medical condition that, in the opinion of the Investigator, could interfere with the study or make participation unsafe; Subjects currently enrolled in other clinical trials, or who have received another investigational product within 30 days prior to study start; Individuals who have not signed the informed consent form.

Where this trial is running

Bologna, BO and 5 other locations

• AOU Policlinico Sant'Orsola Malpighi — Bologna, Bo, Italy (Not_yet_recruiting)
• Università degli Studi Magna Graecia — Catanzaro, Cz, Italy (Not_yet_recruiting)
• IRCCS San Raffaele Pisana — Roma, Roma, Italy (Recruiting)
• Ospedale Policlinico Agostino Gemelli — Roma, Roma, Italy (Not_yet_recruiting)
• Azienda ULSS7 Pademontana Regione Veneto — Bassano del Grappa, Vi, Italy (Not_yet_recruiting)
• Vi.Gi. Centro Polispecialistico — Vibo Valentia, Vv, Italy (Recruiting)

Study contacts

• Study coordinator: Francesco Salvo

Conditions Prodromal to Chronic Venous Disease