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

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.

Timeline

Start

2024-11-06

Primary completion

2025-05-05

Completion

2025-06-11

Publications

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

Drugs

Indications