Status:
COMPLETED
Clinical Trial of Aesculus Hippocastanum and Associations Versus Diosmina and Hesperidina in Chronic Venous Insuficiency
Lead Sponsor:
Fundação Educacional Serra dos Órgãos
Conditions:
Chronic Venous Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To demonstrate the clinical non-inferiority of efficacy between Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, Rutin and Diosmin 450mg and Hesperidin 50mg tablets in the improvement of lowe...
Detailed Description
Phlebotonics represent a heterogeneous group of therapeutic products of natural or synthetic origin that exhibit effects on edema and/or symptoms related to chronic venous diseaseThis class of drugs i...
Eligibility Criteria
Inclusion
- Patient presenting CEAP classification from grade C0 to C3 in the evaluation of venous disease of the lower limbs
- Clinical symptoms of chronic venous insufficiency of the lower limbs, defined by the 100mm visual scale performed by the patient between 20mm and 60mm in the most symptomatic lower limb.
- For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraceptives.
- Patient read, understood, signed and dated the free and informed consent form
Exclusion
- Treatment with compression stockings within 2 months of study inclusion date
- Treatment with venotonics within 2 months of the date of inclusion in the study
- Women of reproductive age who are pregnant or breastfeeding, or who do not wish to use contraception during the study period.
- Known allergy or hypersensitivity to any component of the study drug
- Known significant laboratory abnormality
- CEAP Grade Assessment of level 4, 5, or 6.
- Patient with venous disease requiring intravenous chemical surgery/sclerotherapy
- Patient presenting with a painful pathology in addition to venous pain in the lower limbs 9. Patient with a history of thrombosis or thromboembolic disease within 6 months of the date of inclusion in the study
- 10\. Patient with a change in general condition that is incompatible with his/her participation in the study 11. Patient who wishes to become pregnant within 6 months
Key Trial Info
Start Date :
November 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06579482
Start Date
November 6 2024
End Date
June 11 2025
Last Update
January 7 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, Rio de Janeiro, Brazil, 25964004