Chronic Venous Insufficiency, Superficial Vein Thrombophlebitis, Varicose Vein
Conditions
Brief summary
Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or varicose veins combine superficial vein thrombophlebitis.
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.
Interventions
DRUGEsarin Gel
Sponsors
Ten Sun Pharma Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in subject's leg swelling | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment through the adverse events reports | 28 days | — |
| Improvement of patient's quality of life | 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. |
Countries
Taiwan
Outcome results
None listed