RSFAhCHD60T
Self-Paired Clinical Study of the Combination of Aesculus Hippocastanum 10 mg, Polygonum Acre 10 mg, Smilax Papyracea 40 mg, Rutin 20 mg Tablets in Grade 1, 2 or 3 Hemorrhoidal Disease After 60 Days of Treatment
Sponsor study identifier
Secondary identifiers
OTHER · Certificado de Apresentação de Apreciação Ética - Anvisa
interventional
120
1 country
1
Study Start
September 1, 2024
Actual (reported)Primary Completion
September 1, 2025
Actual (reported)Study Completion
November 22, 2025
Actual (reported)To demonstrate the clinical efficacy of the combination of Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and rutin in tablets in improving local symptoms (bleeding, pain, thrombosis, perianal dermatitis, hemorrhoidal nipple prolapse) assessed using a 100mm visual scale (VAS) over 60 days among adult patients with grade 1, 2 or 3 hemorrhoidal disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 22, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2024
Actual (reported)November 22, 2024
Actual (reported)November 26, 2024
Actual (reported)September 1, 2025
Actual (reported)November 22, 2025
Actual (reported)Hemorrhoidal Disease Symptom Score (HDSS) (adapted)
4 questions: 1. How often do you feel pain because of your hemorrhoids? 2. How often do you experience itching or discomfort in your anus? 3. How often do you bleed when you have a bowel movement? 4. How often do you soil your underwear (anal soil)? Possible answers: * Never * Less than once a month * Less than once a week * 1 to 6 days a week * Every day (always)
2 months
Short Health Scale HD (SHSHD)
1. In your opinion, how severe are your symptoms caused by hemorrhoids? 2. Do your symptoms interfere with your daily activities? 3. Are your symptoms causing you a lot of concern? 4. How is your overall sense of well-being? Possible answers: * 1 * 2 * 3 * 4 * 5
2 months
global satisfaction of the patient
3 months
global satisfaction of the physician
3 months
Effectiveness in hemorrhoidal symptoms
3 months
Self-paired study
venotonic
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, Rio de Janeiro, 25964004, Brazil
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.
Carlos Nunes, Professor
Fundação Educacional Serra dos Órgãos
120 participants (actual enrollment reported by the registry).
First Submitted
November 22, 2024
First Posted
November 26, 2024
Study Start
September 1, 2024
Actual (reported)Contact the study team to confirm eligibility.
Bartolo M. [Socioeconomic impact of venous diseases in Italy]. Phlebologie. 1992 Nov-Dec;45(4):423-31. French.
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.
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.
Primary Completion
September 1, 2025
Actual (reported)Study Completion
November 22, 2025
Actual (reported)Last Updated
January 7, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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