Effect of Vitis Vinifera Seed Extract on Venous Reflux Time in Varicose Vein (NCT05851183) | Clinical Trial Compass
CompletedPhase 4
Effect of Vitis Vinifera Seed Extract on Venous Reflux Time in Varicose Vein
South Korea200 participantsStarted 2023-07-20
Plain-language summary
The number of patients with lower extremity varicose veins has been increasing due to an aging population, with treatments divided into conservative and invasive methods. Current treatments can be expensive and inaccessible for some patients. Entelon, a relatively inexpensive intravenous drug, has shown promise in improving symptoms related to venous lymphatic dysfunction, but its objective vascular function improvement hasn't been proven. This study aims to assess the effectiveness of Vitis Vinifera seed extract (Entelon®) combined with lifestyle therapy in patients with varicose veins, using follow-up Doppler ultrasonography to measure venous reflux improvement.
Who can participate
Age range19 Years – 80 Years
SexALL
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Inclusion criteria
✓. Adult males and females aged between 19 and under 80 years old
✓. Patients with the following findings on venous Doppler ultrasound examination:
✓. Patients who have completed the washout period as described below by Visit 2, including the screening period:
✓. Patients who voluntarily provide written informed consent to participate in this clinical trial
Exclusion criteria
✕. Peripheral arterial occlusive disease in the lower limbs
✕. Asymptomatic lower extremity varicose veins
✕. Acute deep vein thrombosis
✕. Frequent lower limb pain due to neuropathy
✕. Patients who have undergone or are scheduled for varicose vein procedures/surgeries (However, patients who have had a procedure or surgery more than 1 year prior to the screening date are eligible to participate)
. Patients diagnosed with systemic diseases causing edema or thrombosis, such as heart failure, endocrine diseases (hypothyroidism, Cushing's syndrome, uncontrolled diabetes), allergic reactions to medications, urticaria and angioedema, malabsorption and protein-calorie malnutrition, obstructive sleep apnea, or thrombophilia, as determined by the investigator
✕. History of malignancy within the past 5 years, but the following cases are eligible for clinical trial participation:
✕. Severe renal dysfunction (serum creatinine levels more than twice the normal upper limit of the institution) at the screening date