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

NCT ID: NCT06748014

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2025-12-31

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[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

Detailed Description

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

Keywords

hemorrhoid; MPFF; Asecin

Study Design

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

Study Groups

MPFF + Placebo

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

Group Type: PLACEBO_COMPARATOR

MPFF

Intervention Type: DRUG

MPFF 3000 mg 7 day then 1000 mg 2 months

MPFF + Aescin

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

Group Type: ACTIVE_COMPARATOR

Aescin in Horse Chestnut

Intervention Type: DRUG

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

MPFF

Intervention Type: DRUG

MPFF 3000 mg 7 day then 1000 mg 2 months

Interventions

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

Intervention Type: DRUG

MPFF

MPFF 3000 mg 7 day then 1000 mg 2 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Acute active bleeding hemorrhoid grade 1 and 2 with in 7 days
• Age over 20 years
• In patients aged over 50 years, it is imperative to confirm the absence of any alternative causes of bleeding through a colonoscopy
• Can follow up in 6 months

Exclusion Criteria

• Bleeding disorder
• History of colorectal cancer, inflammatory bowel disease, portal hypertension, chronic kidney disease grade 3 or over
• Patient required other treatment such as hemorrhoidectomy or RBL
• Patient who received antiplatelet or anticoagulant
• Physical exam reveals anal fissure
• Pregnancy
• Any psychotic disorder
• Refuse to participate

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Witcha Vipudhamorn

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

WITCHA VIPUDHAMORN, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Colorectal Surgery, Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

Locations

Chiangmai university

Chiang Mai, Maung, Thailand

Countries

Thailand

Other Identifiers

SUR-2567-0485

Identifier Type: -

Identifier Source: org_study_id