clinical non-inferiority study between diosmin 600mg & diosmin + hesperidin in symptomatic chronic venous insufficiency

Conditions: Venous Insufficiency

Summary: clinical non-inferiority study between diosmin 600 mg tablets and diosmin 900 mg + hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. prospective, single-blind, randomized study in parallel groups (total patient population 120, 60 subjects per treatment group), with a total of 4 clinical assessment at months 0, 2, 4, and 6 of treatment.

the primary study objective is to demonstrate the clinical non inferiority of efficacy between diosmin 600 mg tablets versus combination diosmin 900 mg + hesperidin 100 mg tablets in improving lower limb symptoms assessed by a 100 mm visual analogue scale (vas) over 6 months among adult patients presenting chronic venous insufficiency of the lower limbs. the secondary study objectives are to compare between diosmin 600 mg tablets and combination diosmin 900 mg + hesperidin 100 mg tablets in terms of: * the oral acceptability, * the tolerability, * the global patient's satisfaction, * the global physician's satisfaction. clinical assessments will take place at the study center during the study visits at m0, m2, m4 and m6 including: * efficacy on venous symptoms : the vas of 100 mm is rated by the patient from "0" = absence of venous symptoms up to "100" = maximal intensity of the venous symptoms. the vas is completed by the patient at the investigator's office. this vas globally assesses the venous symptomatology of the most symptomatic leg : heavy legs, painful legs, tired legs, sensation of swelling and/or tension in the legs). * acceptability : easiness to swallow assessed by a vas of 100 mm rated by the patient from "0" = very easy to swallow, up to "10" = very difficult to swallow * patient's global satisfaction related to the treatment efficacy : four levels scale rated as following : bad, acceptable, good, and very good * investigator's global satisfaction related to the treatment efficacy : four levels scale rated as following : bad, acceptable, good, and very good * tolerability (related adverse events) * compliance : accountability of treatments returned by the patient the primary endpoint will be the change between the vas symptoms scores at m0 and m6 / end of study visit (early withdrawal). secondary endpoints include assessments of efficacy, oral acceptability of study drug, and tolerance.

Eligibility criteria:
inclusion criteria: * patients of both genders \>18 years old * patient presenting a c0 to c3 venous disease grade of the lower limbs, according to the clinical component of the ceap classification, * clinical symptoms of chronic venous insufficiency of the lower limbs as defined by a vas of 100 mm rated by the patient between 20 mm and 60 mm on the most symptomatic leg. the vas is a global evaluation of the following symptoms: heavy legs, painful legs, tired legs, sensation of swelling and / or tension in the legs. * premenopausal female subjects not pregnant or breastfeeding, in use of reliable contraceptive * subject has read, understood, dated and signed the informed consent form exclusion criteria: * treatment by compression stocking within the 2 months before inclusion * treatment by venotonics within the 2 months before inclusion * premenopausal women who are pregnant, breastfeeding or who do not wish to use contraception during the study period * known allergy or hypersensitivity to any component of the study drug * known clinically significant laboratory alterations * ceap levels 4, 5 \& 6 * patient with venous disease requiring surgery / chemical endovenous sclerotherapy * patient suffering from a painful pathology other than the venous pain in the lower limbs * patient with history of venous thrombosis or thromboembolic disease within the 6 months before inclusion * patient with alteration of general condition incompatible with his / her participation in the trial * patient wishing to be pregnant in the 6 following months

Keywords: chronic venous insufficiency diosmin hesperidin