To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with swelling of calf and ankle due to disorder of leg venous reflux.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Global improvement on a five point scale
The degree of improvement was evaluated according to change of severity of each symptom at the time of enrollment (baseline) and in Week 12 after initiation of dosing (or at discontinuation)
Time frame: week 12
Number of patients with adverse drug reactions
Time frame: up to week 12
Improvement per symptom on a five point scale
Time frame: 12 weeks
Change in circumference measurements of calf in centimetres
Time frame: baseline, 12 weeks
Change in circumference measurements of ankle in centimetres
Time frame: baseline, 12 weeks
Subject's impression on improvement on a five point scale
Time frame: baseline, 12 weeks
Number of patients with of adverse events
Time frame: up to 12 weeks
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