Randomized Study of Oral Aesculus Hippocastanum and Combinations in Hemorrhoidal Disease After 60 Days of Treatment (RSFAhCHD60T)

January 2, 2026 updated by: Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemorrhoidal Disease Symptom Score (HDSS) (adapted)
Time Frame: 2 months

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)
Time Frame: 2 months
  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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
global satisfaction of the patient
Time Frame: 3 months

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
Time Frame: 3 months

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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness in hemorrhoidal symptoms
Time Frame: 3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundação Educacional Serra dos Órgãos

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidade Federal Fluminense
Universidade Federal do Rio de Janeiro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carlos Nunes, Professor, Fundação Educacional Serra dos Órgãos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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