Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT02346058
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2015-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-19', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2015-01-19', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in subject's leg swelling", 'timeFrame': '28 days', '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.'}, {'measure': "Change in subject's leg pain", 'timeFrame': '28 days', '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.'}], 'secondaryOutcomes': [{'measure': 'Safety Assessment through the adverse events reports', 'timeFrame': '28 days'}, {'measure': "Improvement of patient's quality of life", 'timeFrame': '28 days', '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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Venous Insufficiency', 'Varicose Vein', 'Superficial Vein Thrombophlebitis']}, 'descriptionModule': {'briefSummary': 'Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or varicose veins combine superficial vein thrombophlebitis.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "1. Inclusion Criteria:\n\n * Patients of both sexes, aged above 20 years old.\n * 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).\n * 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)\n * Diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.\n2. Exclusion Criteria:\n\n * Known allergy to the product's ingredients\n * pregnant or breastfeeding\n * patient is joining to any other clinical trail\n * Patient has not sign the informed consent form\n * Deep vein thrombosis\n * Cellulitis\n * Stasis dermatitis\n * The patient is taking non-steroids anti-inflammatory drugs( include oral ,topical creams or patch form)"}, 'identificationModule': {'nctId': 'NCT02346058', 'briefTitle': 'Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ten Sun Pharma Company Limited'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SF13136A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esarin Gel', '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.\n\nDosage and frequency: Approx. 3-5 cm Gel was applied topically on skin.twice daily.\n\nDuration: 28 days.', 'interventionNames': ['Drug: Esarin Gel']}], 'interventions': [{'name': 'Esarin Gel', 'type': 'DRUG', 'armGroupLabels': ['Esarin Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'state': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Chung C. Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ten Sun Pharma Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}