Anorectal DisorderNCT06363513
The Efficacy of Aescin in Combination With MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids, A Randomized Controlled Trial
A study testing Aescin in Horse Chestnut and Flavonoid in people with Anorectal Disorder, run by Chiang Mai University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anorectal Disorder
- What is being tested?
- Aescin in Horse Chestnut and Flavonoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2024to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Maharaj Chiang Mai hospital
Chiang Mai, Maung, 50200
WITCHA VIPUDHAMORN, FRCS, 0863645085, witcha.vip@cmu.ac.th
About this study
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
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.
- Conditions
- Anorectal Disorder
- Being tested
- Aescin in Horse Chestnut, Flavonoid
- Keywords
- hemorrhoid, bleeding
- Medical subject headings
- Rectal Diseases, Hemorrhoids, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aescin in Horse ChestnutDrug
Can aescin reduce bleeding in early hemorrhoid
FlavonoidDrug
Also called MPFF
Can combine aescin and MPFF reduce bleeding in early hemorrhoid
| Study group | Role | What they receive |
|---|---|---|
| MPFF with aescin group | Experimental | Not described Receives: Drug: Aescin in Horse Chestnut; Drug: Flavonoid |
| MPFF group | Active comparator | Not described Receives: Drug: Flavonoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of bleeding
day that patient no bleed of hemorrhoid
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Witcha Vipudhamorn, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363513
- Sponsor's protocol ID
- SUR2567-0150
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: published
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06363513
- Acronym / sponsor ID
- SUR2567-0150
- Conditions
- Anorectal Disorder
- Keywords
- hemorrhoid, bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPFF with aescin group | Experimental | Drug: Aescin in Horse Chestnut, Drug: Flavonoid |
| MPFF group | Active comparator | Drug: Flavonoid |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- History of bleeding disorder
- History of colorectal cancer, inflammatory bowel disease, chronic kidney disease
- Physical exam reveals anal fissure
- Pregnancy
- Any psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aescin in Horse ChestnutCan aescin reduce bleeding in early hemorrhoid | Drug | MPFF with aescin group |
| FlavonoidAlso: MPFFCan combine aescin and MPFF reduce bleeding in early hemorrhoid | Drug | MPFF group, MPFF with aescin group |
Primary outcome
Cessation of bleeding
Time frame: 7 days
day that patient no bleed of hemorrhoid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No. published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aescin in Horse Chestnut and Flavonoid in people with Anorectal Disorder, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WITCHA VIPUDHAMORN, FRCS (0863645085, witcha.vip@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of bleeding (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.