The Efficacy of Aescin in Combination With Micronized Purified Flavonoid Fraction (MPFF) in the Control of Bleeding and Prevent Recurrence of Acute Internal Hemorrhoids, A Randomized Controlled Trial, A Pilot 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\[8\]. 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. Multiple trials substantiate MPFF's efficacy in ceasing bleeding, alleviating symptoms, and preventing hemorrhoid relapse. A recent randomized controlled trial shows that MPFF can cease bleeding hemorrhoids in 3 to 4 days.

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. In the past, we used aescin for hemorrhoid treatment benefit in reducing mass effect with control bleeding postoperative hemorrhoidectomy. Based on our previous project (SUR-2567-0150), the combination of aescin with MPFF has demonstrated significant efficacy in stopping bleeding and reducing the mass effect in Grade 1 and 2 hemorrhoids. We aim to study the long-term effects of this combination over 1, 3, and 6 months. This study seeks to provide valuable insights that could inform and refine therapeutic strategies for managing hemorrhoids, ultimately improving patient outcomes

Conditions

• Hemorrhoid

Interventions

DRUG

Aescin in Horse Chestnut

Patient will recived MPFF 3000 mg for 7 day then 1000 mg for 2 month + Aescin 60 mg for 2 month

DRUG

MPFF

MPFF 3000 mg 7 day then 1000 mg 2 months

Sponsors & Collaborators

• Chiang Mai University

  lead OTHER

Principal Investigators

• WITCHA VIPUDHAMORN, MD · Division of Colorectal Surgery, Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-20

Primary Completion

2025-07-31

Completion

2025-12-31

Countries

• Thailand

Study Locations