Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency

Multicenter, Prospective, Randomized, Double-Blind Study to Assess the Therapeutic Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency

The purpose of this study is to assess the therapeutic efficacy and safety of Venocur Triplex®, administered BID for 60 days in patients with Chronic Venous Insufficiency rated between CEAP 2 and 4, in comparison to a Placebo group.

Inclusion Criteria:

• The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC)
• Patients of both sexes, aged above 18 years and below 65 years
• Presence of uni- or bilateral varicose veins with CVI, in both sexes
• The patient's CVI is rated between functional classes CEAP 2 and 4
• Present at least one symptom of CVI prior to the study - leg pains, cramps, fatigue, heavy legs sensation.

Exclusion Criteria:

• If female, the patient has circulatory disorders exclusively during the pre-menstrual period
• If the patient is pregnant or breastfeeding
• The patient has received anticoagulants less than 15 days before study start
• The patient has used steroids or anti-inflammatory drugs less than 8 days before study start
• The patient has received radio or chemotherapy less than 7 days before study start
• The patient has used diuretics, phlebotrophic and venoactive drugs over the past 8 days before enrollment in the study
• The patient has used compression stockings less than 8 days before study start
• Trauma or surgical treatment over the past 30 days before study start
• Prior surgical treatment related to CVI (past 12 months for surgery and past 6 months for sclerotherapy)
• Immobilization of lower limbs over the past 6 months
• Known allergy to the product's ingredients
• Presence of chronic inflammatory diseases (rheumatoid arthritis, for instance), severe chronic infectious diseases (AIDS, tuberculosis, hanseniasis, etc.)
• The patient has suffered from phlebitis or deep venous thrombosis in the past 6 months before the study
• Fibrous lymphedema, primary or secondary lymphedema and lipoedema;
• Concomitant erysipelas
• Active fungal infections of the lower limbs
• Peripheral arteries disease, cerebrovascular or coronary disease
• Severe systemic conditions (heart failure, liver, pulmonary or kidney failure, active neoplastic disease, severe arterial hypertension, uncontrolled diabetes, among others), over the past 6 months before study start
• Hematocrit: < 32.0 mL RBC/dL for women and < 36.0 mL RBC/dL for men
• Hemoglobin: < 11.0 mL g/dL for women and < 12.0 mL g/dL for men;
• Total protein and fractions: Total protein < 6.4 g/dL, Albumin < 4.0 g/dL, Globulin < 1g/dL and Albumin/Globulin < 0.9%
• Serum creatinine: > 1.0 mg/dL for women and > 1.2 mg/dL for men or if patient in dialysis
• Aminotranferases (SGOT/AST and/or SGPT/ALT) more than twice the upper normal limit
• Participation in study with similar objectives over the past 6 months.