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

NCT ID: NCT06579482

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2025-02-11

Brief Summary

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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

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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

Conditions

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Chronic Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, non-inferiority, double-blind ,comparative study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
coated tablets

Study Groups

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Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and Rutina

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

Group Type EXPERIMENTAL

Aesculus hippocastanum, and associations

Intervention Type DRUG

combination product

Diosmina, and Hesperidina

Diosmina 450mg e Hesperidina 50mg

Group Type ACTIVE_COMPARATOR

Aesculus hippocastanum, and associations

Intervention Type DRUG

combination product

Interventions

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Aesculus hippocastanum, and associations

combination product

Intervention Type DRUG

Other Intervention Names

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no other intervention names

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação Educacional Serra dos Órgãos

OTHER

Sponsor Role lead

Responsible Party

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Carlos Pereira Nunes

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Nunes, Professor

Role: PRINCIPAL_INVESTIGATOR

Fundação Educacional Serra dos Órgãos

Locations

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Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Carlos Nunes, Professor

Role: CONTACT

Phone: 552126417088

Email: [email protected]

Romualdo Gama, Professor

Role: CONTACT

Phone: 552126417088

Email: [email protected]

Facility Contacts

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Carlos P Nunes, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 18276714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23761871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12936900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16119324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7798803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18277340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22466974 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8995346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22895941 (View on PubMed)

Other Identifiers

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50635421.30000.5248

Identifier Type: -

Identifier Source: org_study_id