Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins

Evaluate the Efficacy and Safety of Esarin Gel in the Treatment of Chronic Venous Insufficiency or Varicose Vein Combine With Superficial Vein Thrombophlebitis in Outpatient

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.

1. Inclusion Criteria:

   • Patients of both sexes, aged above 20 years old.
   • The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC).
   • Presence of chronic venous insufficiency which is rated between functional classes CEAP 0 and 3.(CEAP Classes: C0:no visible or palpable signs of venous disease, C1:telangiectasies or reticular veins. C2 :apparent Varicose veins, C3 :Edema)
   • Diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.

2. Exclusion Criteria:

   • Known allergy to the product's ingredients
   • pregnant or breastfeeding
   • patient is joining to any other clinical trail
   • Patient has not sign the informed consent form
   • Deep vein thrombosis
   • Cellulitis
   • Stasis dermatitis
   • The patient is taking non-steroids anti-inflammatory drugs( include oral ,topical creams or patch form)