Clinical trial NCT06579482: Clinical Trial of Aesculus Hippocastanum and Associations Versus Diosmina and Hesperidina in Chronic Venous Insuficiency
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Venous Insufficiency
Lead sponsor: Fundação Educacional Serra dos Órgãos
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, non-inferiority, double-blind ,comparative study
Primary purpose: TREATMENT

Brief 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.

Detailed 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

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

Primary outcomes:
measure: visual analogic scale
timeFrame: 3 months
Secondary outcomes:
measure: Oral acceptability by the patient through the use of a visual analogic scale
timeFrame: 3 months
measure: Quality of life as measured by a specific chronic venous insufficiency questionnaire
timeFrame: 3 months
measure: Medical tolerability to tested drugs as measured by the investigator
timeFrame: 3 months
measure: Patient's satisfaction to study medications
timeFrame: 3 months
measure: Physician's satisfaction to study medications
timeFrame: 3 months
Other outcomes:
Locations:
city: Teresópolis
country: Brazil
facility: Centro Universitário Serra dos Órgãos - UNIFESO
state: RJ
Study officials:
affiliation: Fundação Educacional Serra dos Órgãos
name: Carlos Nunes, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nicolaides AN, Allegra C, Bergan J, Bradbury A, Cairols M, Carpentier P, Comerota A, Delis C, Eklof B, Fassiadis N, Georgiou N, Geroulakos G, Hoffmann U, Jantet G, Jawien A, Kakkos S, Kalodiki E, Labropoulos N, Neglen P, Pappas P, Partsch H, Perrin M, Rabe E, Ramelet AA, Vayssaira M, Ioannidou E, Taft A. Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence. Int Angiol. 2008 Feb;27(1):1-59. No abstract available.
citation: Rabe E, Guex JJ, Puskas A, Scuderi A, Fernandez Quesada F; VCP Coordinators. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol. 2012 Apr;31(2):105-15.
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citation: Perera N, Liolitsa D, Iype S, Croxford A, Yassin M, Lang P, Ukaegbu O, van Issum C. Phlebotonics for haemorrhoids. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD004322. doi: 10.1002/14651858.CD004322.pub3.