Study to determine the efficacy and tolerability of two dose levels of Antistax relative to placebo in patients suffering from CVI grade I or incipient grade II
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
260
Changes from baseline of limb volume
determined by water displacement
Time frame: Baseline, day 84
Changes of limb volume
determined by water displacement
Time frame: Baseline, days 42 and 98
Measurement of calf circumference
in centimeters
Time frame: Baseline, days 42, 84 and 98
Measurement of ankle circumference
in centimeters
Time frame: Baseline, days 42, 84 and 98
Assessment of subjective symptoms on a visual analogue scale (VAS)
Time frame: Baseline, days 42, 84 and 98
Assessment of global efficacy by patient on a 4-point verbal rating scale
Time frame: days 42, 84 and 98
Assessment of global efficacy by investigator on a 4-point verbal rating scale
Time frame: days 42, 84 and 98
Assessment of global tolerability by patient on a 4-point verbal rating scale
Time frame: days 42, 84 and 98
Assessment of global tolerability by investigator on a 4-point verbal rating scale
Time frame: days 42, 84 and 98
Number of patients with adverse events
Time frame: up to 14 weeks
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