None listed
Conditions
Interventions
Drug : The group of patient for drug therapy will wear stockings and take Entelon 150 mg twice daily orally for 12 weeks.
The group of patient for only lifestyle modifications will wear stockings and
Sponsors
Kyung Hee University Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 years and older and under 65 years. 2) CEAP classification: C2–C4, Ep (primary), As (anatomical abnormality present), Pr (reflux present). 3) Individuals exhibiting symptoms due to varicose veins (such as pain, itching, numbness, cramps, discomfort in the legs, swelling, heaviness, etc.). 4) Individuals with Doppler ultrasound results showing reflux of 0.5 seconds or more in at least one of the great saphenous vein, small saphenous vein, or perforating veins. 5) Individuals who have completed the washout period as follows, up to the second visit including the screening period: Pain relievers, steroids, and anti-inflammatory medications: more than 2 weeks. 6) Patients who have voluntarily given written consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Individuals with peripheral vascular occlusive disease in the lower limbs. 2. Patients with asymptomatic or secondary varicose veins. 3. Individuals diagnosed with acute deep vein thrombosis. 4. Individuals with frequent leg pain due to neuropathy. 5. Individuals with a BMI > 30 kg/m² (obesity) who are unable to walk. 6. Individuals diagnosed with systemic diseases that cause edema or thrombosis, such as: o Heart failure, endocrine disorders (hypothyroidism, Cushing's syndrome, uncontrolled diabetes), allergy reactions to other medications, urticaria and angioedema, malabsorption and protein-calorie malnutrition, obstructive sleep apnea, thrombosis, or any condition deemed related to edema or thrombosis by the investigator. 7. Individuals with a history of malignant tumors within 5 years prior to the screening point, except in the following cases where participation in the clinical trial is allowed: (1) A history within 5 years prior to the screening point, but currently in a complete remission without recurrence or metastasis. (2) At least 5 years have passed since the completion of treatment for the tumor and currently in a disease-free state. (3) At least 1 year has passed since complete resection of basal cell carcinoma/squamous cell carcinoma, radical resection of papillary thyroid carcinoma, or successful treatment of cervical intraepithelial carcinoma before the screening point. 8. Individuals with severe renal impairment (serum creatinine level more than twice the upper limit of normal as defined by the study site) at the screening point. 9. Individuals with severe liver impairment (ALT or AST levels more than three times the upper limit of normal as defined by the study site) at the screening point. 10. Individuals requiring diuretics or medications and therapies that could affect the results of this clinical trial, except for patients who have been taking antihypertensive medications (calcium channel blockers, beta blockers, angiotensin-converting enzyme inhibitors, vasodilators, vasoconstrictors) at the same dose for at least 2 weeks (14 days) prior to the screening and maintain the same medication and dosage during the study. 11. Individuals with a history of clinically significant mental disorders, alcohol abuse, etc. 12. Individuals with a history of hypersensitivity to the investigational drug or its components. 13. Individuals who have participated in another clinical trial (involving investigational drugs, medical devices, health supplements) within 12 weeks prior to the screening point or plan to participate in one. 14. Pregnant or breastfeeding individuals. 15. Women of childbearing potential who plan to become pregnant during the study period. 16. Individuals deemed inappropriate for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AVVQ (Aberdeen Varicose Vein Questionnaire);CIVIQ-20 (CHRONIC VENOUS INSUFFICIENCY QUESTIONNAIRE-20);Pain;Ankle diameter | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance;Complication | — |
Countries
Korea, Republic of
Contacts
Public ContactJin Hyun Joh
Kyung Hee University Hospital at Gangdong
Outcome results
None listed