Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or varicose veins combine superficial vein thrombophlebitis.
Open-label,non-controlled study design with three visits (pre-treatment/baseline, treatment day 14 and day 28). Administered Esarin Gel twice daily for 28 days in subjects with chronic venous insufficiency rated between CEAP 0 and 3 or varicose veins combine superficial vein thrombophlebitis, in comparison to the pre-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Taichung Veterans General Hospital
Taichung, Taichung, Taiwan
Change in subject's leg swelling
Change from pre-treatment (baseline) in the thigh circumference on treatment day 14 and day 28. Using the tape measure to measure the thigh circumference.
Time frame: 28 days
Change in subject's leg pain
Change from pre-treatment (baseline) in subject's leg pain on treatment day 14 and day 28. For the assessment of pain, a numerical rating scale (0-10; 0(zero) meaning "no pain" and 10 (ten) "the worst pain") is used.
Time frame: 28 days
Safety Assessment through the adverse events reports
Time frame: 28 days
Improvement of patient's quality of life
Improvement of patient's general activities, mood and sleeping from pre-treatment (baseline) to day 14 and day 28 during Esarin Gel treatment period.
Time frame: 28 days
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