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

NCT ID: NCT02346058

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Chronic Venous Insufficiency; Varicose Vein; Superficial Vein Thrombophlebitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Esarin Gel

Intervention Type: DRUG

Interventions

Esarin Gel

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ten Sun Pharma Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chung C. Wang

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

Taichung Veterans General Hospital

Taichung, Taichung, Taiwan

Countries

Taiwan

Other Identifiers

SF13136A

Identifier Type: -

Identifier Source: org_study_id