Trial | NCT02346058  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    53
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 Started
Oct 31
2013
Primary Completion
Jun 30
2014
Study Completion
Oct 31
2014
Last Update
Jan 26
2015
Estimate

Drug Esarin Gel

Esarin Gel Experimental

Dosage form:One tube of Esarin Gel contains 20 gm of compound. Each gm contains:10 mg Heparinoid, 10 mg Escin, 50 mg Diethylamine Salicylate. Dosage and frequency: Approx. 3-5 cm Gel was applied topically on skin.twice daily. Duration: 28 days.

Criteria 

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.

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)
No Results Posted