Chronic Venous Insufficiency Clinical Trial
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
Verified date | June 2013 |
Source | Ten Sun Pharma Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Ministry of Health and Welfare |
Study type | Interventional |
Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or varicose veins combine superficial vein thrombophlebitis.
Status | Completed |
Enrollment | 53 |
Est. completion date | October 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Taichung Veterans General Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
Ten Sun Pharma Company Limited |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | Safety Assessment through the adverse events reports | 28 days | Yes | |
Secondary | Improvement of patient's quality of life | Improvement of patient's general activities, mood and sleeping from pre-treatment (baseline) to day 14 and day 28 during Esarin Gel treatment period. | 28 days | No |
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