Clinical Trial of Aesculus Hippocastanum and Associations Versus Diosmina and Hesperidina in Chronic Venous Insuficiency

Launched by FUNDAÇÃO EDUCACIONAL SERRA DOS ÓRGÃOS · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a natural treatment made from Aesculus hippocastanum (also known as horse chestnut) and other herbal ingredients, compared to a combination of Diosmin and Hesperidin, in helping adults with chronic venous insufficiency (CVI). CVI is a condition where the veins in the legs have trouble sending blood back to the heart, often causing symptoms like pain, swelling, and heaviness in the legs. The goal of the trial is to see if the natural treatment works just as well as the standard treatment over a period of three months, as measured by how much patients feel their symptoms improve.

To be eligible for the study, patients should be between the ages of 65 and 74 and have specific symptoms of CVI that can be measured on a scale from 0 to 100. They should not have used compression stockings or certain medications in the last two months, and women of childbearing age need to be using reliable birth control. Participants will need to provide informed consent, meaning they understand the study and agree to take part. If you or someone you know fits these criteria and is interested, this trial could be an opportunity to explore new treatment options for managing CVI symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient presenting CEAP classification from grade C0 to C3 in the evaluation of venous disease of the lower limbs
• • 2. 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.
• • 3. For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraceptives.
• • 4. Patient read, understood, signed and dated the free and informed consent form
• Exclusion Criteria:
• • 1. Treatment with compression stockings within 2 months of study inclusion date
• • 2. Treatment with venotonics within 2 months of the date of inclusion in the study
• • 3. Women of reproductive age who are pregnant or breastfeeding, or who do not wish to use contraception during the study period.
• • 4. Known allergy or hypersensitivity to any component of the study drug
• • 5. Known significant laboratory abnormality
• • 6. CEAP Grade Assessment of level 4, 5, or 6.
• • 7. Patient with venous disease requiring intravenous chemical surgery/sclerotherapy
• • 8. 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