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

NCT ID: NCT06363513

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-05-31

Brief 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.

Conditions

Anorectal Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MPFF with aescin group

Group Type: EXPERIMENTAL

Aescin in Horse Chestnut

Intervention Type: DRUG

Can aescin reduce bleeding in early hemorrhoid

Flavonoid

Intervention Type: DRUG

Can combine aescin and MPFF reduce bleeding in early hemorrhoid

MPFF group

Group Type: ACTIVE_COMPARATOR

Flavonoid

Intervention Type: DRUG

Can combine aescin and MPFF reduce bleeding in early hemorrhoid

Interventions

Aescin in Horse Chestnut

Can aescin reduce bleeding in early hemorrhoid

Intervention Type: DRUG

Flavonoid

Can combine aescin and MPFF reduce bleeding in early hemorrhoid

Intervention Type: DRUG

Other Intervention Names

MPFF

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Witcha Vipudhamorn

FRCS MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maharaj Chiang Mai hospital

Chiang Mai, Maung, Thailand

Countries

Thailand

Central Contacts

WITCHA VIPUDHAMORN, FRCS

Role: CONTACT

witcha.vip@cmu.ac.th

0863645085

Facility Contacts

WITCHA VIPUDHAMORN, FRCS

Role: primary

witcha.vip@cmu.ac.th

0863645085

Other Identifiers

SUR2567-0150

Identifier Type: -

Identifier Source: org_study_id