To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
202
LKH Graz
Graz, Austria
AKH Wien
Vienna, Austria
VENEX Venenexperten
Vienna, Austria
Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.
Time frame: 84 days
Change from baseline in limb volume on days 21 and 42 determined by water displacement.
Time frame: 21 and 42 days
Change from baseline in calf circumference on days 21, 42, and 84
Time frame: 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
Time frame: 21, 42 and 84 days
Global assessment of efficacy by the patient on day 84
Time frame: 84 days
Global assessment of efficacy by the investigator on day 84
Time frame: 84 days
Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84
Time frame: 84 days
Incidence of adverse events
Time frame: 84 days
Measurement of vital signs (pulse rate, blood pressure)
Time frame: 84 days
Global assessment of tolerability by the patient and by the investigator on day 84.
Time frame: day 84
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Boehringer Ingelheim Investigational Site
Brno, Czechia
Neurology-geriatric Institute
Moravský Beroun, Czechia
Boehringer Ingelheim Investigational Site
Berlin, Germany
Klinik und Poliklinik der Universitat Bonn
Bonn, Germany
Boehringer Ingelheim Investigational Site
Cologne, Germany
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau, Germany
Klinik und Poliklinik fur Hautkrankheiten
Greifswald, Germany
...and 6 more locations