Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins
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|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.
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 ClinicalTrials.gov identifier (NCT number): NCT02346058
|Taichung Veterans General Hospital|
|Taichung, Taiwan, 40705|
|Principal Investigator:||Chung C. Wang||Taichung Veterans General Hospital|