Comparing two treatments for chronic venous insufficiency

Clinical Study of Non-inferiority Between Aesculus Hippocastanum 50mg, Polygonum Acre 10mg, Smilax Pepyracea 40mg, Rutin 20mg Versus Diosmin 450mg and Hesperidin 50mg Tablets in Chronic Venous Insufficiency After 3 Months of Therapy

This study is testing if a natural treatment called Aesculus hippocastanum works just as well as a standard medication for improving symptoms in adults with chronic venous insufficiency.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundação Educacional Serra dos Órgãos (other)
• Locations: 1 site (Teresópolis, RJ)
• Trial ID: NCT06579482 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to demonstrate the non-inferiority of Aesculus hippocastanum and its associated compounds compared to Diosmin and Hesperidin in treating symptoms of chronic venous insufficiency. The study will assess the improvement of lower limb symptoms over a period of three months using a visual analog scale (VAS). Eligible adult patients with specific CEAP classifications and symptom severity will be enrolled, while those with recent treatments or certain health conditions will be excluded. The trial focuses on evaluating the effectiveness of phlebotonics, a class of drugs known for their benefits in venous diseases.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic venous insufficiency classified as CEAP grades C0 to C3 and experiencing moderate symptoms.

Not a fit: Patients with severe chronic venous insufficiency (CEAP grades 4 to 6) or those recently treated with venotonics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment for patients suffering from chronic venous insufficiency.

How similar studies have performed: Previous studies have shown promising results with phlebotonics in treating chronic venous insufficiency, indicating that this approach is supported by existing evidence.

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

Where this trial is running

Teresópolis, RJ

• Centro Universitário Serra dos Órgãos - UNIFESO — Teresópolis, RJ, Brazil (RECRUITING)

Study contacts

• Principal investigator: Carlos Nunes, Professor — Fundação Educacional Serra dos Órgãos
• Study coordinator: Carlos Nunes, Professor

Conditions: Chronic Venous Insufficiency