Chronic venous insufficiency Circulatory System Venous insufficiency (chronic)(peripheral)
Conditions
Interventions
Participants will be randomized to be treated with either one tablet taken daily of Micronized Purified Flavonoid Fraction 1000 mg or two 500 mg tablets taken daily for 8 weeks.
Sponsors
Institut de Recherches Internationales Servier (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged 20 to 70 years old (inclusive) 2. Out-patient 3. Suffering from primary chronic venous disease (leg pain greater or equal to 4 cm on Visual Analog Scale) 4. Clinical class C0s to C4s on the most affected leg (CEAP classification)
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding or possibility of becoming pregnant 2. Recent non-authorized nonpharmacological treatments (sclerotherapy; surgical treatment of varicose veins, angioplasty; endovascular devices) 3. Recent compression therapy and/or physical therapy of legs 4. Active venous thrombosis, significant chronic deep venous obstruction leading to venous claudication and significant compression therapy 5. All causes of leg pain in lower limbs others than CVD symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (clinical acceptability) assessed at each visit (week 0, week 2, week 4 and week 8). Safety assessment takes into account adverse events, weight, sitting blood pressure and heart rate, laboratory examination and leg pain by Visual Analog Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcomes. | — |
Countries
Russian Federation, Serbia
Outcome results
None listed