Phase
Condition
Varicose Veins
Vascular Diseases
Occlusions
Treatment
Therapeutic lifestyle change only
Lifestyle modification
Vitis Vinifera seed extract medication plus therapeutic lifestyle change
Clinical Study ID
Ages 19-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult males and females aged between 19 and under 80 years old
Patients with the following findings on venous Doppler ultrasound examination:
Superficial veins (such as the great saphenous vein, small saphenous vein,etc.) showing valvular reflux for 0.5 seconds or longer
Deep veins (such as the femoral vein, etc.) showing valvular reflux for 1second or longer
- Patients who have completed the washout period as described below by Visit 2,including the screening period:
- Analgesics, steroids, anti-inflammatory drugs, and venoactive medications (suchas Entelon, etc.): at least 4 weeks
- Patients who voluntarily provide written informed consent to participate in thisclinical trial
Exclusion
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 thescreening date are eligible to participate)
Patients diagnosed with systemic diseases causing edema or thrombosis, such as heartfailure, endocrine diseases (hypothyroidism, Cushing's syndrome, uncontrolleddiabetes), allergic reactions to medications, urticaria and angioedema,malabsorption and protein-calorie malnutrition, obstructive sleep apnea, orthrombophilia, as determined by the investigator
History of malignancy within the past 5 years, but the following cases are eligiblefor clinical trial participation:
Those who have a history within the past 5 years but maintain a cured statewithout recurrence or metastasis
Those who have completed treatment for their tumor and have been disease-freefor at least 5 years from the screening date
Those who have passed at least 1 year since the screening date after completeresection of basal cell carcinoma/squamous cell carcinoma, radical resection ofthyroid papillary cancer, or successful treatment of cervical intraepithelialneoplasia
Severe renal dysfunction (serum creatinine levels more than twice the normal upperlimit of the institution) at the screening date
Severe liver dysfunction (ALT or AST levels more than three times the normal upperlimit of the institution) at the screening date
Need to receive diuretics or contraindicated medications and therapies that mayaffect the results of this clinical trial during the study period (However, patientswho have been taking antihypertensive medications (calcium channel blockers,beta-blockers, angiotensin-converting enzyme inhibitors, vasodilators,vasoconstrictors) at the same dosage for at least 4 weeks (28 days) before screeningand will maintain the same dosage and administration during the study period areeligible to participate)
History of clinically significant psychiatric disorders or alcohol abuse
History of hypersensitivity reactions to the investigational drug or its ingredients
Those who have participated in or are scheduled to participate in other clinicaltrials (investigational drugs, medical devices, health functional foods) within 12weeks from the screening date
Pregnant or breastfeeding women
Women of childbearing potential who plan to become pregnant during the clinicaltrial participation period
Individuals deemed unsuitable for participation in the clinical trial by theinvestigator
Study Design
Study Description
Connect with a study center
Yongin Severance Hospitall, Yonsei University College of Medicine
Yongin, Gyeonggi-do 16995
Korea, Republic ofSite Not Available
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