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Anorectal DisorderNCT06363513

The Efficacy of Aescin in Combination With MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids, A Randomized Controlled Trial

A study testing Aescin in Horse Chestnut and Flavonoid in people with Anorectal Disorder, run by Chiang Mai University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hemorrhoidal disease, characterized by symptomatic enlargement and distal displacement of anal cushions, has been a subject of recognition and management for centuries. The etymology of "hemorrhoid" is traced back to the Greek words haima (blood) and rhoos (flow). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Anorectal Disorder
What is being tested?
Aescin in Horse Chestnut and Flavonoid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteThailand
Study dates
Apr 2024to May 2024
Phase
Interventional
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • New case acute hemorrhoid grade 1 and 2
  • Age over 18 years
  • In patients aged over 50 years, it is imperative to confirm the absence of any alternative causes of bleeding through a colonoscopy
  • Can long term follow up

Who cannot join

  • History of bleeding disorder
  • History of colorectal cancer, inflammatory bowel disease, chronic kidney disease
  • Physical exam reveals anal fissure
  • Pregnancy
  • Any psychotic disorder
  • Refuse to participate

Trial locations and contacts

1 site in 1 country.

WITCHA VIPUDHAMORN, FRCS contact

0863645085

witcha.vip@cmu.ac.th

Thailand1 site
  • Maharaj Chiang Mai hospital

    Chiang Mai, Maung, 50200

    WITCHA VIPUDHAMORN, FRCS, 0863645085, witcha.vip@cmu.ac.th

Other trials in Thailand

About this study

Official title: The Efficacy of Aescin in Combination With Micronized Purified Flavonoid Fraction (MPFF) in the Early Control of Bleeding From Acute Internal Hemorrhoids, A Randomized Controlled Trial

Hemorrhoidal disease, characterized by symptomatic enlargement and distal displacement of anal cushions, has been a subject of recognition and management for centuries. The etymology of "hemorrhoid" is traced back to the Greek words haima (blood) and rhoos (flow). Prevalent in over 20% of the population across various life stages, this anorectal condition impacts both genders. The multifaceted development of the disease incorporates theories encompassing abnormal dilation of hemorrhoidal plexuses, distension of arteriovenous anastomoses, prolapse of anal pads, and a myriad of genetic, anatomical, dietary, and lifestyle factors. Manifestations range from venous distension to bleeding and thrombosis, with classification based on location (internal/external/combined) and degree of prolapse (grade 1-4).

Upon comprehensive history-taking and examinations, including digital rectal and proctoscope assessments, a definitive diagnosis is established, leading to the treatment phase. Although outpatient procedures demonstrate efficacy, patients may persist with pain and discomfort. Medical intervention assumes significance for stages 1 and 2, incorporating approaches such as rubber-band ligation, injection sclerotherapy, and dietary modifications. Micronized Purified Flavonoid Fraction (MPFF), integral to hemorrhoid treatment, has been scrutinized for its ability to mitigate pathogenic processes culminating in acute bleeding. The stagnation of blood in vascular plexuses prompts an inflammatory response, activating white cells and increasing vessel wall permeability. MPFF's flavonoid compounds are posited to alleviate bleeding by augmenting venous tone, reducing stasis, inhibiting inflammatory mediators, and enhancing lymphatic drainage[8]. Multiple trials substantiate MPFF's efficacy in ceasing bleeding, alleviating symptoms, and preventing hemorrhoid relapse.

Aescin, a saponin mixture found in Aesculus hippocastanum (horse chestnut). The primary active component, β-aescin, contributes to the plant's medicinal attributes. Experimental investigations in animal models underscore its anti-edematous, anti-inflammatory, and venotonic properties, attributed to molecular mechanisms facilitating ion entry into channels and elevating venous tension. While the therapeutic benefits of aescin for hemorrhoids are acknowledged, the absence of randomized control trials impedes the conclusive validation of its efficacy. In the realm of diverse treatment options, this proposed randomized controlled trial aims to assess the comparative effectiveness of combining aescin with MPFF versus MPFF alone in managing hemorrhoid-related symptoms. The study aspires to furnish valuable insights for refining therapeutic strategies in the management of hemorrhoids and enhancing patient outcomes.

Being tested
Aescin in Horse Chestnut, Flavonoid
Keywords
hemorrhoid, bleeding
Medical subject headings
Rectal Diseases, Hemorrhoids, Hemorrhage

What participants receive

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

  • Aescin in Horse ChestnutDrug

    Can aescin reduce bleeding in early hemorrhoid

  • FlavonoidDrug

    Also called MPFF

    Can combine aescin and MPFF reduce bleeding in early hemorrhoid

Study groups in NCT06363513
Study groupRoleWhat they receive
MPFF with aescin groupExperimentalNot described
Receives: Drug: Aescin in Horse Chestnut; Drug: Flavonoid
MPFF groupActive comparatorNot described
Receives: Drug: Flavonoid

What is being measured

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

  1. Cessation of bleeding

    day that patient no bleed of hemorrhoid

    Measured: 7 days

Timeline

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

  1. First posted12 Apr 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06363513
Sponsor's protocol ID
SUR2567-0150
Status last verified
Apr 2024
First submitted
9 Apr 2024
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: published

Questions about this trial

What is this clinical trial studying?

A study testing Aescin in Horse Chestnut and Flavonoid in people with Anorectal Disorder, run by Chiang Mai University at 1 site in Thailand.

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 6 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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 Thailand. 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.

Are results available for this study?

Results are not available in the source record.

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

Contact WITCHA VIPUDHAMORN, FRCS (0863645085, witcha.vip@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cessation of bleeding (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Apr 2024.

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