NCT05851183

Effect of Vitis Vinifera Seed Extract on Venous Reflux Time in Varicose Vein

A Prospective, Open-label, Pragmatic Randomized Controlled Trial to Demonstrate the Effect of Improving the Venous Reflux Time by Vitis Vinifera Seed Extract in Patients With Varicose Vein of Lower Extremity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Varicose veins in the lower extremities are more than the function of the valve membranes on the inside of the legs, and the heart cannot function, resulting in regurgitation in the lower half of the body. This causes blood to pool in the lower extremities and causes various symptoms. Large stalks of superficial veins and venous valves of deep veins become dysfunctional, resulting in an increase in blood vessels in the calf area with backflow of blood. The valvular insufficiency of lower extremity veins is the main cause. In general, it occurs in the great saphenous vein that flows into the deep vein from the groin, the small saphenous vein in the posterior leg, and the perforating vein in the calf. Reflux in superficial veins (e.g. great saphenous vein, small saphenous vein) and deep veins can generally be confirmed using Doppler ultrasound. Determine the direction of treatment by confirming if there is branch vein dilatation. Ultrasonography is also done on the opposite, unaffected side, even if symptoms are in only one leg. Treatment of varicose veins can generally be divided into conservative treatment and invasive treatment, and lifestyle correction and wearing compression stockings are recommended as conservative treatment. Surgical treatment is indicated when conservative treatment is ineffective or interferes with daily life. Symptoms can be alleviated by removing superficial veins with regurgitation due to valvular insufficiency, or by inducing hardening of the causative blood vessels using high frequency or laser to block regurgitation and prevent blood flow. However, most of these treatments are non-salary items, and are relatively expensive treatment methods that impose a large financial burden on patients. In addition, deep veins are responsible for 90% of blood transport, but surgical treatment is impossible and only conservative treatment is possible. As a non-invasive treatment, which is an intravenous active agent, is registered as a drug to be administered, and improvement of symptoms related to venous lymphatic dysfunction (pain, lower extremity anxiety symptoms) is attracting attention. It is relatively inexpensive compared to surgical treatment, but until now, objective improvement of vascular function by drug treatment has not been proven. Vitis Vinifera seed extract (Entelon®) was launched in 1998 and its safety has already been confirmed, and the investigators have investigated the effect of lower limit volume reduction compared to placebo after administration of Vitis Vinifera seed extract in patients with edema. (Sano A, Tokutake S, Seo A. Proanthocyanidin-rich grape seed extract reduces leg swelling in healthy women during prolonged sitting. J Sci Food Agric. 2013 Feb;93(3):457-62.). In this study, along with lifestyle therapy in patients with varicose veins, follow-up Doppler ultrasonography after administration of Entelon will be used to confirm the improvement effect of venous reflux.

Conditions

• Varicose Veins of Lower Limb

Interventions

Type	Name	Description
DRUG	Vitis Vinifera seed extract medication plus therapeutic lifestyle change	Administer 150mg of Vitis Vinifera seed extract (Entelon®) orally twice a day
BEHAVIORAL	Therapeutic lifestyle change only	Implementing TLCs is a critical component of a comprehensive treatment plan for varicose veins. A key aspect of TLCs is the optimization of postural habits. Patients are advised to avoid extended sitting or standing periods, which exert additional pressure on the venous system in the lower extremities and exacerbate venous insufficiency. During rest periods, elevating the legs closer to the heart is recommended because this simple yet effective adjustment promotes venous return and reduces the gravitational burden on the venous valves of the legs. The use of graduated compression stockings during waking hours is another therapeutic lifestyle intervention that is often prescribed for patients with varicose veins. Additional TLCs include maintaining optimal body weight and engaging in regular physical exercise Walking or cycling are often recommended because of their effectiveness in promoting lower limb venous return.

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-09-30
• Completion: 2025-01-30
• First posted: 2023-05-09
• Last updated: 2025-03-04

Locations

1 site across 1 country: South Korea