Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundação Educacional Serra dos Órgãos

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