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OpenTrials
Completed

NCT Number: NCT02346058

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

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

Esarin Gel

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ten Sun Pharma Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2015
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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