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

Last updated: August 27, 2024
Sponsor: Fundação Educacional Serra dos Órgãos
Overall Status: Active - Recruiting

Phase

4

Condition

Venous Thrombosis

Claudication

Varicose Veins

Treatment

Aesculus hippocastanum, and associations

Clinical Study ID

NCT06579482
50635421.30000.5248
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient presenting CEAP classification from grade C0 to C3 in the evaluation ofvenous 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 mostsymptomatic lower limb.

  3. For female patients of reproductive age, not pregnant or breastfeeding, usingreliable contraceptives.

  4. Patient read, understood, signed and dated the free and informed consent form

Exclusion

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 touse 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 lowerlimbs 9. Patient with a history of thrombosis or thromboembolic disease within 6months of the date of inclusion in the study

  9. Patient with a change in general condition that is incompatible with his/herparticipation in the study 11. Patient who wishes to become pregnant within 6 months

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Aesculus hippocastanum, and associations
Phase: 4
Study Start date:
November 06, 2023
Estimated Completion Date:
February 11, 2025

Study 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 is effective in improving the symptoms of chronic venous insufficiency and in cases of hemorrhoids and for this reason they have become an established component of the therapeutic arsenal for all phases of these diseases Phlebotomics are classified into four categories: benzopyrones, saponins, other plant extracts, and synthetic drugs

Connect with a study center

  • Centro Universitário Serra dos Órgãos - UNIFESO

    Teresópolis, RJ 25964004
    Brazil

    Active - Recruiting

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