Venous Insufficiency
Conditions
Brief summary
To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms
Interventions
DRUGRead vine leaf extract (AS 195)
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement. | 84 days |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in calf circumference on days 21, 42, and 84 | 21, 42 and 84 days |
| Change from baseline in the subjective symptoms of CVI (tired heavy legs, sensation of tension in the legs, tingling sensations in the legs, pain in the legs) measured by visual analogue scales (VAS) on days 21, 42, and 84 | 21, 42 and 84 days |
| Global assessment of efficacy by the patient on day 84 | 84 days |
| Global assessment of efficacy by the investigator on day 84 | 84 days |
| Change from baseline in limb volume on days 21 and 42 determined by water displacement. | 21 and 42 days |
| Incidence of adverse events | 84 days |
| Measurement of vital signs (pulse rate, blood pressure) | 84 days |
| Global assessment of tolerability by the patient and by the investigator on day 84. | day 84 |
| Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84 | 84 days |
Countries
Austria, Czechia, Germany
Outcome results
None listed