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

NCT02346058 | Completed Phase 4

• 1 other identifier: SF13136A
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Venous Insufficiency; Varicose Vein; Superficial Vein Thrombophlebitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Safety Assessment through the adverse events reports

  28 days

• Improvement of patient's quality of life

  28 days

Study Arms (1)

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.

Drug: Esarin Gel

Interventions

Esarin Gel DRUG

Esarin Gel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ten Sun Pharma Company Limited: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taichung, 40705, Taiwan

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chung C. Wang

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 26, 2015
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 26, 2015

Record last verified: 2013-06

Locations

TW (1)