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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Venous Insufficiency, Varicose Vein, Superficial Vein Thrombophlebitis

Intervention / Treatment
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* Drug: Esarin Gel


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esarin Gel<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment through the adverse events reports |  | 28 days | 
| 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 |