Randomized Study of Oral Aesculus Hippocastanum and Combinations in Hemorrhoidal Disease After 60 Days of Treatment
NCT ID: NCT06705777
Last Updated: 2026-01-07
Study Results
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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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2024-09-01
2025-11-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aesculus hippocastanum, and interventions
Self-paired study
Aesculus hippocastanum, and interventions
venotonic
Interventions
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Aesculus hippocastanum, and interventions
venotonic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Complaints related to haemorrhoidal disease/acute hemorrhoidal crisis (defined as acute anal pain due to haemorrhoidal prolapse with or without bleeding, edema and thrombosis)
* For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraception.
* Patient has read, understood, signed and dated the informed consent form
Exclusion Criteria
* Treatment with venotonics within 2 months of the date of inclusion in the study
* 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 medication
* Known significant laboratory abnormality
* Anal fissure
* Inflammatory bowel disease
* Colorectal cancer
* Anal abscess or fistula
* Previous anorectal surgery and/or radiotherapy in the pelvic-perineal region
* Patient with a change in general condition that is incompatible with her participation in the study
* Patient who wishes to become pregnant within 6 months
* Inability of the patient to understand the nature of the study and follow the doctor's recommendations
18 Years
ALL
No
Sponsors
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Universidade Federal do Rio de Janeiro
OTHER
Universidade Federal Fluminense
OTHER
Fundação Educacional Serra dos Órgãos
OTHER
Responsible Party
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Carlos Pereira Nunes
Professor
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
Countries
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References
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Bergan JJ, Schmid-Schonbein GW, Coleridge Smith PD, Nicolaides AN, Boisseau MR, Eklof B. Chronic venous disease. Minerva Cardioangiol. 2007 Aug;55(4):459-76. No abstract available. English, Italian.
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.
Zagriadskii EA, Bogomazov AM, Golovko EB. Conservative Treatment of Hemorrhoids: Results of an Observational Multicenter Study. Adv Ther. 2018 Nov;35(11):1979-1992. doi: 10.1007/s12325-018-0794-x. Epub 2018 Oct 1.
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.
Ba-bai-ke-re MM, Huang HG, Re WN, Fan K, Chu H, Ai EH, Li-Mu MM, Wang YR, Wen H. How we can improve patients' comfort after Milligan-Morgan open haemorrhoidectomy. World J Gastroenterol. 2011 Mar 21;17(11):1448-56. doi: 10.3748/wjg.v17.i11.1448.
Bartolo M. [Socioeconomic impact of venous diseases in Italy]. Phlebologie. 1992 Nov-Dec;45(4):423-31. French.
Dickson S, Gallagher J, McIntyre L, Suter A, Tan J. An open study to assess the safety and efficacy of Aesculus hippocastanum tablets (Aesculaforce 50mg) in the treatment of chronic venous insufficiency. J Herb Pharmacother. 2004;4(2):19-32.
Park G, Kim TM, Kim JH, Oh MS. Antioxidant effects of the sarsaparilla via scavenging of reactive oxygen species and induction of antioxidant enzymes in human dermal fibroblasts. Environ Toxicol Pharmacol. 2014 Jul;38(1):305-15. doi: 10.1016/j.etap.2014.06.009. Epub 2014 Jun 28.
Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.
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.
Other Identifiers
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83102224.6.0000.5247
Identifier Type: OTHER
Identifier Source: secondary_id
7.078.287
Identifier Type: -
Identifier Source: org_study_id
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