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

Fundação Educacional Serra dos Órgãos

Status and phase: Enrolling; Phase 4

Conditions: Chronic Venous Insufficiency

Treatments: Drug: Aesculus hippocastanum, and associations

Study type: Interventional

Funder types: Other

Identifiers

NCT06579482

50635421.30000.5248

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

9. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 2 patient groups

Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and Rutina

Experimental group

Description:

Aesculus hippocastanum 50mg, Polygonum acre 10mg, Smilax Pepyracea 40mg, Rutina 20mg

Treatment:

Drug: Aesculus hippocastanum, and associations

Diosmina, and Hesperidina

Active Comparator group

Description:

Diosmina 450mg e Hesperidina 50mg

Treatment:

Drug: Aesculus hippocastanum, and associations