Diosmin has a well established use status in improvement of the symptoms of venolymphatic insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of capillary fragility. Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo, to establish its efficacy in the pain relief in Chronic Venous Disease (CVD). The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600 mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre, controlled, randomised, double blind, placebo-controlled, parallel-group study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
378
tablet, 600mg, PO, 1 tab per day during 28 days
tablet, PO, 1 per day during 28 days
Dr Jean-Jérôme GUEX
Nice, France
Change of Visual analog Scale score for assessment of the painful venous symptomatology
Time frame: baseline and after 28 days
- Painful symptom intensity (daily VAS score) Area Under the Curve
Time frame: 28 days
- Daily VAS score for Response rate
Time frame: 28 days
- Daily VAS score for Time to response
Time frame: 28 days
- Score of Quality of life questionnaire (SQOR-V)
Time frame: Between baseline and 28 days
- Patient's and physician's global satisfaction score
Time frame: At 28 days
Adverse Events (numbers and frequency)
Time frame: 28 days
- Unusual intakes of analgesic treatments (rate of patients)
Time frame: 28 days
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