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

Ten Sun Pharma

Status and phase: Completed; Phase 4

Conditions: Superficial Vein Thrombophlebitis; Varicose Vein; Chronic Venous Insufficiency

Treatments: Drug: Esarin Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02346058

SF13136A

Details and patient eligibility

About

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

Full description

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.

Enrollment: 53 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Esarin Gel

Experimental group

Description:

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.

Treatment:

Drug: Esarin Gel