The Efficacy of Aescin in Combination With MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids, A Randomized Controlled Trial - Trial NCT06363513

Timeline & Enrollment

Primary Outcome

Cessation of bleeding

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.

ICD-10 Classifications