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To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Read vine leaf extract (AS 195) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement. | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in limb volume on days 21 and 42 determined by water displacement. | 21 and 42 days | |
| Change from baseline in calf circumference on days 21, 42, and 84 | 21, 42 and 84 days | |
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Graz | Graz | Austria | ||||
| AKH Wien |
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| 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 quality of life as determined by the Tuebingen QoL Questionnaire on day 84 | 84 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 |
| Vienna |
| Austria |
| VENEX Venenexperten | Vienna | Austria |
| 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 |
| Klinikum der Johannes Gutenberg-Universitat | Mainz | Germany |
| Gesundheitszentrum Minden | Minden | Germany |
| Boehringer Ingelheim Investigational Site | München | Germany |
| Boehringer Ingelheim Investigational Site | Oberkirch | Germany |
| Boehringer Ingelheim Investigational Site | Rottweil | Germany |
| Universitats-Hautklinik | Tübingen | Germany |
| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C499994 | AS 195 |
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