An open comparative randomized clinical study of the efficacy and safety of Phlebofa in the treatment of chronic venous insufficiency of lower limbs
Objective. To study the efficacy and safety of Phlebofa 600 in comparison with the drug, Phlebodia 600 in the treatment of chronic venous insufficiency of the lower limbs. Material and methods. The study included 60 patients - men and women aged from 18 to 70 years old with chronic venous insufficiency 1-4 degrees in CEAR criteria of inclusion and exclusion. The study included: history taking, examination of phlebology, measurement malleolar volume, measurement of weight, height, body temperature, blood pressure, heart rate, and breathing, ultrasonic Doppler sonography with the measurement of the systemic venous pressure and venous pressure in the lower extremities, ultrasound duplex scanning with color mapping blood flow veins of the lower extremities, clinical, biochemical blood, coagulogrammae, urinalysis, women of childbearing age made a pregnancy test. Patients were randomized in the main and control group in the ratio of 1:1. Patients of the main group received treatment with Phlebofa 600, the control group - drug Phlebodia 600. Duration of treatment was 60 days. The present open comparative randomized clinical study was conducted in the framework of phase III clinical trials for the subsequent registration of a medicinal product in the Russian Federation. Evaluated the effectiveness, safety of drugs diosmin, statistical processing of the obtained results. Results. Found a significant improvement in the aggregate of a clinical scale of assessment of the severity of the disease VSCC on a background of treatment as in the main ( p = 0.002) and control ( p = 0,0013) group, a decrease malleolar circumference on a background of treatment as in the main (right p = 0.025, the left p = 0.008), and control ( p = 0.023 and p < 0.0001) group, reducing the diameter of the common femoral vein after treatment in ortostas position ( p = 0.01) and the test Valsalvae ( p = 0.005) in the control group, as well as in the main group the test Valsalvae right ( p < 0.0001) and the left ( p = 0.01), reduction of systemic venous pressure in the face of treatment in main ( p = 0.001) and control ( p = 0.01) group, improvement of life quality indicators on a scale CIVIQ in main ( p = 0.0001) and control ( p < 0.0001) group. Conclusion. On the basic standards of efficiency and security of the Protocol clinical trial, the study medication Phlebofa 600 as the drug Phlebodia 600 comparison.