A Prospective, Open-label, Pragmatic Randomized Control Trial to Demonstrate the Effect of Improving the Venous Reflux Time by Vitis Vinifera Seed Extract in Patients with Varicose Vein of Lower Extremity
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008552
- Lead Sponsor
- Yonsei University Yongin Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 200
1) Adult men and women between the ages of 19 and under 80
2) Patients who meet the results of venous Doppler ultrasonography
- In case of valvular regurgitation for 0.5 seconds or longer in superficial veins (great saphenous vein, small saphenous vein, etc.)
- In case of valvular regurgitation for more than 1 second in deep veins (popliteal veins, etc.)
3) Completed the washout period as below, including the screening period, up to visit 2
- Analgesics, steroids, anti-inflammatory drugs, venoactive (such as Enteron) drugs: 4 weeks or more
4) Patients who voluntarily consent in writing to participate in this clinical trial
1) Patients with peripheral vasoocclusive arterial disease of the lower extremities
2) Patients with asymptomatic varicose veins
3) Subjects diagnosed with acute deep vein thrombosis
4) People with frequent leg pain due to neuropathy
5) Patients or prospective patients undergoing varicose vein surgery/surgical procedure(However, patients who have undergone surgery or surgical procedure for more than 1 year from the time of screening can participate in the study)
6) Subjects who diagnosed with systemic diseases that cause edema or thrombosis, such as: Heart failure, endocrine disorders (hypothyroidism, Cushing's syndrome, uncontrolled diabetes), allergic reactions to other drugs, urticaria and angioedema, malabsorption and protein-calorie malnutrition, obstructive sleep apnea Diseases determined by the examiner to be associated with edema or thrombosis due to thrombosis, etc.
7) Those who have malignant tumor within 5 years from the time of screening. (However, in the following cases, it is possible to participate in clinical trials.)
(1) If you have the ability within 5 years from the time of screening, but you maintain a cured state without recurrence or metastasis
(2) At least 5 years after completion of tumor treatment based on time of screening or if disease-free
(3) At least 1 year after successful treatment for complete resection of basal cell/squamous cell carcinoma, radical resection of papillary thyroid carcinoma, or cervical carcinoma in situ based on screening time point
8) Subjects with severe new functional impairment (serum creatinine value = 2 times the upper limit of normal of the testing laboratory) based on the time of screening
9) Subjects with severe hepatic dysfunction (ALT or AST levels =3 times the laboratory's upper limit of normalization) based on the time of screening
10) Subjects who should receive diuretics or contraindicated drugs and contraindicated therapies that may affect the results of this clinical trial during the clinical trial period
11) Those who have been diagnosed with clinically significant mental illness, alcohol abuse, etc.
12) Persons with a history of hypersensitivity reactions to clinical trial drugs or ingredients of this drug
13) Persons with a history of hypersensitivity reactions to clinical trial drugs or ingredients of this drug
14) people who are pregnant or breastfeeding
15) Women of childbearing potential who plan to become pregnant during the study period
16) Subjects who are determined to be inappropriate for clinical trial participation by the investigator's judgment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method