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

NCT06579482 | Completed Phase 4

• 1 other identifier: 50635421.30000.5248
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• visual analogic scale

  A 100 mm VAS (visual analogic scale) is marked from 0 (absence of venous symptoms) up to 100 (maximum symptomatic venous manifestations) by the patient (higher scores means a worse outcome). It is fulfilled by the patient him- or herself, under the physician's watch. VAS is meant to globally evaluate lower limbs venous symptomatology (heavy legs, painful legs, fatigued legs, deambulation limitations, swollen sensation and/or lower limbs tension).

  3 months

Secondary Outcomes (5)

• Oral acceptability by the patient through the use of a visual analogic scale

  3 months

• Quality of life as measured by a specific chronic venous insufficiency questionnaire

  3 months

• Medical tolerability to tested drugs as measured by the investigator

  3 months

• Patient's satisfaction to study medications

  3 months

• Physician's satisfaction to study medications

  3 months

Study Arms (2)

Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and Rutina

EXPERIMENTAL

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

Drug: Aesculus hippocastanum, and associations

Diosmina, and Hesperidina

ACTIVE COMPARATOR

Diosmina 450mg e Hesperidina 50mg

Drug: Aesculus hippocastanum, and associations

Interventions

Aesculus hippocastanum, and associations DRUG

combination product

Also known as: no other intervention names

Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and Rutina; Diosmina, and Hesperidina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Fundação Educacional Serra dos Órgãos: lead

Study Sites (1)

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, 25964004, Brazil

Location

Related Publications (9)

• Acheson AG, Scholefield JH. Management of haemorrhoids. BMJ. 2008 Feb 16;336(7640):380-3. doi: 10.1136/bmj.39465.674745.80. No abstract available.

  PMID: 18276714 BACKGROUND

• Belczak SQ, Sincos IR, Campos W, Beserra J, Nering G, Aun R. Veno-active drugs for chronic venous disease: A randomized, double-blind, placebo-controlled parallel-design trial. Phlebology. 2014 Aug;29(7):454-60. doi: 10.1177/0268355513489550. Epub 2013 May 16.

  PMID: 23761871 BACKGROUND

• Criqui MH, Jamosmos M, Fronek A, Denenberg JO, Langer RD, Bergan J, Golomb BA. Chronic venous disease in an ethnically diverse population: the San Diego Population Study. Am J Epidemiol. 2003 Sep 1;158(5):448-56. doi: 10.1093/aje/kwg166.

  PMID: 12936900 BACKGROUND

• Kecmanovic D, Pavlov M, Ceranic M, Sepetkovski A, Kovacevi P, Stamenkovic A. [PHLEBODIA (diosmine): a role in the management of bleeding nonprolapsed hemorrhoids]. Acta Chir Iugosl. 2005;52(1):115-6. doi: 10.2298/aci0501115k. Serbian.

  PMID: 16119324 BACKGROUND

• Lafuma A, Fagnani F, Peltier-Pujol F, Rauss A. [Venous disease in France: an unrecognized public health problem]. J Mal Vasc. 1994;19(3):185-9. French.

  PMID: 7798803 BACKGROUND

• 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.

  PMID: 18277340 BACKGROUND

• 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.

  PMID: 22466974 BACKGROUND

• Ruckley CV. Socioeconomic impact of chronic venous insufficiency and leg ulcers. Angiology. 1997 Jan;48(1):67-9. doi: 10.1177/000331979704800111.

  PMID: 8995346 BACKGROUND

• 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.

  PMID: 22895941 BACKGROUND

MeSH Terms

Interventions

horse chestnut seed; Association

Intervention Hierarchy (Ancestors)

Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carlos Nunes, Professor

  Fundação Educacional Serra dos Órgãos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: coated tablets
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, non-inferiority, double-blind ,comparative study

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: August 30, 2024
• Study Start: November 6, 2024
• Primary Completion: May 5, 2025
• Study Completion: June 11, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)