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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02346058
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Varicose Vein Superficial Vein Thrombophlebitis Drug: Esarin Gel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

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

Primary Outcome Measures :
  1. Change in subject's leg swelling [ Time Frame: 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.

  2. Change in subject's leg pain [ Time Frame: 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 :
  1. Safety Assessment through the adverse events reports [ Time Frame: 28 days ]
  2. Improvement of patient's quality of life [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02346058

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Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
Ten Sun Pharma Company Limited
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Principal Investigator: Chung C. Wang Taichung Veterans General Hospital

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Responsible Party: Ten Sun Pharma Company Limited Identifier: NCT02346058     History of Changes
Other Study ID Numbers: SF13136A
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: June 2013

Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Embolism and Thrombosis
Peripheral Vascular Diseases