A Phase 3 interventional study of Read vine leaf extract (AS 195) in Venous Insufficiency, sponsored by Boehringer Ingelheim. Completed at 16 sites in 3 countries. Per ClinicalTrials.gov, last updated 2013-10-29.
Sponsored by Boehringer Ingelheim · Phase 3 and Interventional
To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's enrollment of 202 is above the median of 60 across 139 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim