- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02346058
Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins
January 19, 2015 updated by: Ten Sun Pharma Company Limited
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
Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or varicose veins combine superficial vein thrombophlebitis.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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28 days
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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.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Assessment through the adverse events reports
Time Frame: 28 days
|
28 days
|
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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.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chung C. Wang, Taichung Veterans General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (ACTUAL)
June 1, 2014
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
January 13, 2015
First Submitted That Met QC Criteria
January 19, 2015
First Posted (ESTIMATE)
January 26, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 19, 2015
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SF13136A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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