NCT06705777

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

November 22, 2024

Last Update Submit

January 2, 2026

Conditions

Haemorrhoidal Disease

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • global satisfaction of the patient

    3 months

  • global satisfaction of the physician

    3 months

Other Outcomes (1)

  • Effectiveness in hemorrhoidal symptoms

    3 months

Study Arms (1)

Aesculus hippocastanum, and interventions

OTHER

Self-paired study

Drug: Aesculus hippocastanum, and interventions

Interventions

Aesculus hippocastanum, and interventionsDRUG

venotonic

Also known as: Vastonic
Aesculus hippocastanum, and interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of concomitant severe systemic disorders
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, 25964004, Brazil

Location

Related Publications (10)

  • 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.

    PMID: 18276714BACKGROUND

  • 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.

    PMID: 21472103BACKGROUND

  • Bartolo M. [Socioeconomic impact of venous diseases in Italy]. Phlebologie. 1992 Nov-Dec;45(4):423-31. French.

    PMID: 1302317BACKGROUND

  • 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.

    PMID: 17653022BACKGROUND

  • 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.

    PMID: 23761871BACKGROUND

  • 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.

    PMID: 30276625BACKGROUND

  • 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.

    PMID: 15364642RESULT

  • 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.

    PMID: 25022355RESULT

  • 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.

    PMID: 30451751RESULT

  • 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.

    PMID: 22895941RESULT

MeSH Terms

Interventions

horse chestnut seedMethods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Carlos Nunes, Professor

    Fundação Educacional Serra dos Órgãos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 26, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

November 22, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)