efficacy and safety of the use of venocur triplex® in patients with chronic venous insufficiency

Conditions: Venous Insufficiency

Summary: 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.


Eligibility criteria:
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.

Keywords: chronic venous insufficiency, venocur triplex®