CompletedPhase 4

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

Brazil120 participantsStarted 2024-11-06

Plain-language 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 lower limb symptoms assessed by means of a 100mm visual scale (VAS) over 3 months among adult patients presenting with chronic venous insufficiency of the lower limbs.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

visual analogic scale

Timeframe: 3 months

Trial details

NCT IDNCT06579482

SponsorFundação Educacional Serra dos Órgãos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-05

View on ClinicalTrials.gov More Chronic Venous Insufficiency trials