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

NCT05851183 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-03-04

No results posted yet for this study

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.

Conditions

  • Varicose Veins of Lower Limb

Interventions

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • In Hyun Jung, MD, PhD · Yongin Severance Hospital, Yonsei University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2024-09-30
Completion
2025-01-30

Countries

  • South Korea

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05851183 on ClinicalTrials.gov