Actively Recruiting
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
Led by Ekalab S.r.l. · Updated on 2025-09-22
84
Participants Needed
6
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both sexes
- Age 18 years or older
- Signed informed consent form for participation in the study
- Presence of at least one symptom possibly related to chronic venous disease such as heaviness, swelling, pain, nighttime cramps, tired or heavy legs, itching, burning, warmth, tingling, or restlessness in the lower limbs
- Willingness to participate and comply with study procedures confirmed by signing informed consent
You will not qualify if you...
- Pregnancy or current breastfeeding
- Women of childbearing potential not using adequate birth control methods
- Chronic venous insufficiency classified as CEAP stages C3-C6
- Positive pitting edema sign at initial visit
- Deep vein thrombosis within the last 6 months
- Current or recent (within 4 weeks) use of venoactive or anti-edematous products
- Scheduled surgical procedures within 3 months of enrollment
- History of heart failure (NYHA Class III-IV), chronic kidney disease, or severe hepatic insufficiency
- Ongoing cancer or immunosuppressive diseases
- Celiac disease
- Drug or alcohol abuse
- Neurological or psychiatric disorders affecting consent validity or study adherence
- Known allergy or intolerance to any component of the dietary supplement
- Any condition that could interfere with the study or make participation unsafe
- Current enrollment in other clinical trials or recent use (within 30 days) of investigational products
- Not having signed the informed consent form
AI-Screening
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Trial Site Locations
Total: 6 locations
1
AOU Policlinico Sant'Orsola Malpighi
Bologna, BO, Italy, 40138
Not Yet Recruiting
2
Università degli Studi Magna Graecia
Catanzaro, CZ, Italy, 88100
Not Yet Recruiting
3
IRCCS San Raffaele Pisana
Roma, Roma, Italy, 00163
Actively Recruiting
4
Ospedale Policlinico Agostino Gemelli
Roma, Roma, Italy, 00168
Not Yet Recruiting
5
Azienda ULSS7 Pademontana Regione Veneto
Bassano del Grappa, VI, Italy, 36061
Not Yet Recruiting
6
Vi.Gi. Centro Polispecialistico
Vibo Valentia, VV, Italy, 89900
Actively Recruiting
Research Team
F
Francesco Salvo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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