Prodromal to Chronic Venous DiseaseNCT07185386
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
A study testing combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe) in people with Prodromal to Chronic Venous Disease, run by Ekalab S.r.l. at 4 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prodromal to Chronic Venous Disease
- What is being tested?
- combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesItaly
- Study dates
- 28 May 2025to 18 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
AOU Policlinico Sant'Orsola Malpighi
Bologna, BO, 40138
Università degli Studi Magna Graecia
Catanzaro, CZ, 88100
IRCCS San Raffaele Pisana
Roma, Roma, 00163
Vi.Gi. Centro Polispecialistico
Vibo Valentia, VV, 89900
About this study
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).
- Conditions
- Prodromal to Chronic Venous Disease
- Being tested
- combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| VESVEIN | Experimental | VESVEIN Gambe, (Ekalab S.r.l., Italia) Receives: Dietary Supplement: combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start28 May 2025
- Primary completion22 Jan 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal to Chronic Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ekalab S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185386
- Sponsor's protocol ID
- VSV-25-001
- Status last verified
- May 2026
- First submitted
- 15 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD sharing foreseen
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07185386
- Acronym / sponsor ID
- VSV-25-001
- Conditions
- Prodromal to Chronic Venous Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ekalab S.r.l.Industry (pharma, biotech, devices)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VESVEIN | Experimental | Dietary Supplement: combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe)VESVEIN Gambe, (Ekalab S.r.l., Italia) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe)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. | Dietary supplement | VESVEIN |
Primary outcome
Primary objective
Time frame: 12 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. no IPD sharing foreseen
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe) in people with Prodromal to Chronic Venous Disease, run by Ekalab S.r.l. at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.