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Haemorrhoidal DiseasePhase 4RSFAhCHD60TNCT06705777

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

A Phase 4 study testing Aesculus hippocastanum, and interventions in people with Haemorrhoidal Disease, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Haemorrhoidal Disease
What is being tested?
Aesculus hippocastanum, and interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBrazil
Study dates
1 Sep 2024to 22 Nov 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Centro Universitário Serra dos Órgãos - UNIFESO

    Teresópolis, Rio de Janeiro, 25964004

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Aesculus hippocastanum, and interventions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aesculus hippocastanum, and interventionsDrug

    Also called Vastonic

    venotonic

Study groups in NCT06705777
Study groupRoleWhat they receive
Aesculus hippocastanum, and interventionsOtherSelf-paired study
Receives: Drug: Aesculus hippocastanum, and interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2 months

  2. 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

    Measured: 2 months

Secondary outcomes (2)

  1. 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

    Measured: 3 months

  2. 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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start1 Sep 2024
  3. Primary completion1 Sep 2025
  4. Study completion22 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705777
Sponsor's protocol ID
7.078.287
Other IDs
83102224.6.0000.5247
Acronym
RSFAhCHD60T
Status last verified
Jan 2026
First submitted
22 Nov 2024
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 18276714

  • 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.

    PubMed 21472103

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

    PubMed 1302317

  • 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.

    PubMed 17653022

  • 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.

    PubMed 23761871

  • 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.

    PubMed 30276625

  • 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.

    PubMed 15364642

  • 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.

    PubMed 25022355

  • 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.

    PubMed 30451751

  • 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.

    PubMed 22895941

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aesculus hippocastanum, and interventions in people with Haemorrhoidal Disease, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemorrhoidal Disease Symptom Score (HDSS) (adapted) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06705777, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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