The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.
A randomized, multicentered, open label, comparative study to assess the efficacy and safety of Endolex Forte® versus a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) in reducing the symptomatology of patients diagnosed with Chronic Venous Insufficiency which is rated between functional classes CEAP 1-4, during a period of 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.
A combination of diosmin and hesperidin is a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) film-coated tablets administered from Baseline Visit until Day 180, two tablets per day.
Change from baseline in limb volume determination at day 180 (water displacement method)
Time frame: 180 days
Change from baseline in limb volume determination at day 90 (water displacement method)
Time frame: 90 days
Change from pre-treatment (baseline) in the calf circumference on treatment day 30
Time frame: 30 days
Change from pre-treatment (baseline) in the calf circumference on treatment day 180
Time frame: 180 days
Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 90
Time frame: 90 days
Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 180
Time frame: 180 days
Global assessment of efficacy by the investigator at day 180
Time frame: 180 days
Questionnaire on improvement in symptoms at day 180 (CIVIQ-20)
Time frame: 180 days
Global assessment of tolerability by the investigator at day 180
Time frame: 180 days
Adverse events
Time frame: 180 days
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