Randomized Study of Oral Aesculus Hippocastanum and Combinations in Hemorrhoidal Disease After 60 Days of Treatment (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

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.

Study Overview

• Status: Completed
• Conditions: Haemorrhoidal Disease
• Intervention / Treatment: Drug: Aesculus hippocastanum, and interventions

Detailed Description

Hemorrhoidal disease (HD) is the most common proctological condition, with an up to 86% prevalence (asymptomatic individuals underestimated). It is expected that 5% of the population might have at least one episode of HD during their lifetime, most individuals amenable to medical therapy but 10 to 20% of them requiring surgical intervention. HD has an occurrence peak between the 5th and 7th decades of life. Haemorrhoids can be defined as varicose dilatation of the submucosal anorectal veins due to persistently elevated venous pressure in the hemorrhoidal plexus, that is, they develop when the venous drainage of the anus and rectum is altered, causing dilatation of the venous plexus and connective tissue, creating an overgrowth of the anal mucosa of the rectal wall. The term HD is used when haemorrhoids cause symptoms. Aesculus hippocastanum (horse chestnut), rutin, Smilax papyracea (sarsaparilla), Polygonum acre (dotted smartweed) combination is commonly used to control chronic venous insufficiency (CVI) manifestations. Assuming pathophysiology of HD and CVI are similar, the investigators hypothesized the above combination could be also useful in the management of the former condition.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro
    • Teresópolis, Rio de Janeiro, Brazil, 25964004
      • Centro Universitário Serra dos Órgãos - UNIFESO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Grade 1, 2 or 3 hemorrhoidal disease
• 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:

• Presence of concomitant severe systemic disorders
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Aesculus hippocastanum, and interventions; Self-paired study	Drug: Aesculus hippocastanum, and interventions; venotonic; Other Names: Vastonic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemorrhoidal Disease Symptom Score (HDSS) (adapted)	4 questions: How often do you feel pain because of your hemorrhoids?; How often do you experience itching or discomfort in your anus?; How often do you bleed when you have a bowel movement?; 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)	In your opinion, how severe are your symptoms caused by hemorrhoids?; Do your symptoms interfere with your daily activities?; Are your symptoms causing you a lot of concern?; How is your overall sense of well-being? Possible answers: 1; 2; 3; 4; 5	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
global satisfaction of the patient	Please indicate your overall satisfaction with the effectiveness of your treatment to date on the scale below: Bad; Acceptable; Good; Very Good	3 months
global satisfaction of the physician	Please indicate your overall satisfaction with the effectiveness of your treatment to date on the scale below: Bad; Acceptable; Good; Very Good	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness in hemorrhoidal symptoms	The 100mm visual scale is assessed by the patient between "0" = absence of venous symptoms and "100" = maximum intensity of symptoms. The visual scale is performed by the patient in the presence of the investigator. This visual scale assesses the symptoms of haemorrhoidal disease in a global manner: bleeding, pain, thrombosis, perianal dermatitis (pruritus or anal discomfort), prolapse of the hemorrhoidal nipple, soiling.	3 months

Collaborators and Investigators

• Sponsor: Fundação Educacional Serra dos Órgãos
• Collaborators: Universidade Federal Fluminense; Universidade Federal do Rio de Janeiro
• Investigators: Principal Investigator: Carlos Nunes, Professor, Fundação Educacional Serra dos Órgãos

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): November 22, 2025

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Methods; horse chestnut seed
• Other Study ID Numbers: 7.078.287; 83102224.6.0000.5247 (Other Identifier: Certificado de Apresentação de Apreciação Ética - Anvisa)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No