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

Primary Purpose

Chronic Venous Insufficiency, Varicose Vein, Superficial Vein Thrombophlebitis

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Esarin Gel
Sponsored by
Ten Sun Pharma Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Insufficiency

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  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)

Sites / Locations

  • Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Esarin Gel

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Safety Assessment through the adverse events reports
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.

Full Information

First Posted
January 13, 2015
Last Updated
January 19, 2015
Sponsor
Ten Sun Pharma Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02346058
Brief Title
Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ten Sun Pharma Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency, Varicose Vein, Superficial Vein Thrombophlebitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esarin Gel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Esarin Gel
Primary Outcome Measure Information:
Title
Change in subject's leg swelling
Description
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.
Time Frame
28 days
Title
Change in subject's leg pain
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Safety Assessment through the adverse events reports
Time Frame
28 days
Title
Improvement of patient's quality of life
Description
Improvement of patient's general activities, mood and sleeping from pre-treatment (baseline) to day 14 and day 28 during Esarin Gel treatment period.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung C. Wang
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan

12. IPD Sharing Statement

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

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