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临床试验/NCT06363513
NCT06363513尚未招募不适用

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

Chiang Mai University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Cessation of bleeding

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • New case acute hemorrhoid grade 1 and 2
  • Age over 18 years
  • In patients aged over 50 years, it is imperative to confirm the absence of any alternative causes of bleeding through a colonoscopy
  • Can long term follow up

排除标准

  • History of bleeding disorder
  • History of colorectal cancer, inflammatory bowel disease, chronic kidney disease
  • Physical exam reveals anal fissure
  • Pregnancy
  • Any psychotic disorder
  • Refuse to participate

研究组 & 干预措施

MPFF with aescin group

Experimental

干预措施: Aescin in Horse Chestnut (Drug)

MPFF with aescin group

Experimental

干预措施: Flavonoid (Drug)

MPFF group

Active Comparator

干预措施: Flavonoid (Drug)

结局指标

主要结局

Cessation of bleeding

时间窗: 7 days

day that patient no bleed of hemorrhoid

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Witcha Vipudhamorn

FRCS MD

Chiang Mai University

研究点 (1)

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