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Not yet recruitingNCT06363513Updated Apr 12, 2024

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

An interventional study of Aescin in Horse Chestnut and Flavonoid in Anorectal Disorder, sponsored by Chiang Mai University. Not yet recruiting at 1 site in Thailand. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-12.

Primary conditionHemorrhoidsRegistry: Rectal DiseasesReclassifiedWhy we changed it
Registry
Rectal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hemorrhoids
Why
  1. The study's title name Hemorrhoids, a narrower term within Rectal Diseases.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Chiang Mai University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
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Study 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). 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.

02

Conditions studied

  • Anorectal Disorder

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Keywords

  • hemorrhoid
  • bleeding
03

In context

Hemorrhoids Reclassified

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

Chiang Mai University is the lead sponsor of 119 studies on the registry; 12 are open to participants now.

Compared within Hemorrhoids, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Rectal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    MPFF with aescin group

    Drug: Aescin in Horse Chestnut · Drug: Flavonoid

  • Active comparator
    MPFF group

    Drug: Flavonoid

Interventions

  • DrugAescin in Horse Chestnut

    Can aescin reduce bleeding in early hemorrhoid

  • DrugFlavonoid

    Drug pages: Flavonoids · Flavonols · Dietary Flavonoid

    Can combine aescin and MPFF reduce bleeding in early hemorrhoid

    Also known as: MPFF

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What researchers measure

Primary outcomes

  1. Cessation of bleeding

    day that patient no bleed of hemorrhoid

    Time frame: 7 days

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Study locations

1 site
  • Maharaj Chiang Mai hospital
    Chiangmai, Maung 50200, Thailand
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References and documents

Individual participant data

Plan to share: No — published

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06363513
Responsible party
Witcha Vipudhamorn (FRCS MD, Chiang Mai University) — Principal investigator
First posted
Apr 12, 2024
Start date
Apr 2024 (estimated)
Primary completion
May 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Apr 12, 2024

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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