Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363513
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
The Efficacy of Aescin in Combination With MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids A Randomized Controlled Trial
Sponsor:
Chiang Mai University
Organization:
Chiang Mai University
Study Overview
Official Title:
The Efficacy of Aescin in Combination With Micronized Purified Flavonoid Fraction MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 internalexternalcombined 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 MPFFs flavonoid compounds are posited to alleviate bleeding by augmenting venous tone reducing stasis inhibiting inflammatory mediators and enhancing lymphatic drainage8 Multiple trials substantiate MPFFs 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 plants 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
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 MPFFs flavonoid compounds are posited to alleviate bleeding by augmenting venous tone reducing stasis inhibiting inflammatory mediators and enhancing lymphatic drainage8 Multiple trials substantiate MPFFs 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 plants 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None