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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or varicose veins combine superficial vein thrombophlebitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ten Sun Pharma Company Limited

Criteria

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)