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.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency; Varicose Vein; Superficial Vein Thrombophlebitis
• Intervention / Treatment: Drug: Esarin Gel

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Esarin Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subject's leg swelling	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.	28 days
Change in subject's leg pain	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.	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ten Sun Pharma Company Limited
• Investigators: Principal Investigator: Chung C. Wang, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 19, 2015
• First Posted (ESTIMATE): January 26, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 19, 2015
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Vasculitis; Venous Thrombosis; Thrombosis; Peripheral Vascular Diseases; Phlebitis; Venous Insufficiency; Varicose Veins; Thrombophlebitis
• Other Study ID Numbers: SF13136A