Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins
|ClinicalTrials.gov Identifier: NCT02346058|
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Venous Insufficiency Varicose Vein Superficial Vein Thrombophlebitis||Drug: Esarin Gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- Safety Assessment through the adverse events reports [ Time Frame: 28 days ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346058
|Taichung Veterans General Hospital|
|Taichung, Taiwan, 40705|
|Principal Investigator:||Chung C. Wang||Taichung Veterans General Hospital|