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

NCT06748014 | Enrolling By Invitation Early Phase 1 DMC

• 1 other identifier: SUR-2567-0485
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Hemorrhoid

Keywords

hemorrhoid; MPFF; Asecin

Outcome Measures

Primary Outcomes (1)

• Recurrence of hemorrhoid

  Present of bleeding or protuding mass in1 3 6 month

  6 months

Secondary Outcomes (1)

• Stop bleeding in acute phase

  7 day

Study Arms (2)

MPFF + Placebo

PLACEBO COMPARATOR

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

Drug: MPFF

MPFF + Aescin

ACTIVE COMPARATOR

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

Drug: Aescin in Horse Chestnut; Drug: MPFF

Interventions

Aescin in Horse Chestnut DRUG

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

MPFF + Aescin

MPFF DRUG

MPFF 3000 mg 7 day then 1000 mg 2 months

MPFF + Aescin; MPFF + Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Chiangmai university

Chiang Mai, Maung, 50200, Thailand

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Escin; horse chestnut seed

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals; Saponins; Glycosides; Carbohydrates

Study Officials

• WITCHA VIPUDHAMORN, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient and assessor doctor dont know what medication the patient recieved.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 24, 2024
• Study Start: December 20, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months
• Access Criteria: contact via email

Locations

TH (1)