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

Phase 4

Completed

• Conditions: Superficial Vein Thrombophlebitis; Chronic Venous Insufficiency; Varicose Vein
• Interventions: Drug: Esarin Gel

• Registration Number: NCT02346058
• Lead Sponsor: Ten Sun Pharma Company Limited

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2013-06
• Study Start: 2013-10
• Primary Completion: 2014-06
• Study Completion: 2014-10
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-19
• Last Update Submitted: 2015-01-19
• Study First Posted: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esarin Gel	Esarin Gel	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.

Primary Outcome Measures

Name	Time	Method
Change in subject's leg swelling	28 days	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.
Change in subject's leg pain	28 days	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.

Secondary Outcome Measures

Name	Time	Method
Improvement of patient's quality of life	28 days	Improvement of patient's general activities, mood and sleeping from pre-treatment (baseline) to day 14 and day 28 during Esarin Gel treatment period.
Safety Assessment through the adverse events reports	28 days

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan