An Early Phase 1 interventional study of Aescin in Horse Chestnut and MPFF in Hemorrhoid, sponsored by Chiang Mai University. Enrolling by invitation at 1 site in Thailand. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Chiang Mai University · Early Phase 1, Interventional, and Treatment
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
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
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Chiang Mai University is the lead sponsor of 119 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Patient will recived MPFF 3000 mg for 7 day then 1000 mg for 2 month + placebo
Drug: MPFF
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
Patient will recived MPFF 3000 mg for 7 day then 1000 mg for 2 month + Aescin 60 mg for 2 month
MPFF 3000 mg 7 day then 1000 mg 2 months
Recurrence of hemorrhoid
Present of bleeding or protuding mass in1 3 6 month
Time frame: 6 months
Stop bleeding in acute phase
Compare efficacy of bleeding cessation in 7 day
Time frame: 7 day
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: 6 months
Access criteria: contact via email
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Jul 2025, 7 months after the start.
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