Randomized Study of Oral Aesculus Hippocastanum and Combinations in Hemorrhoidal Disease After 60 Days of Treatment (RSFAhCHD60T)

Fundação Educacional Serra dos Órgãos

Status and phase: Completed; Phase 4

Conditions: Haemorrhoidal Disease

Treatments: Drug: Aesculus hippocastanum, and interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT06705777

83102224.6.0000.5247 (Other Identifier)

7.078.287

Details and patient eligibility

About

To demonstrate the clinical efficacy of the combination of Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and rutin in tablets in improving local symptoms (bleeding, pain, thrombosis, perianal dermatitis, hemorrhoidal nipple prolapse) assessed using a 100mm visual scale (VAS) over 60 days among adult patients with grade 1, 2 or 3 hemorrhoidal disease.

Full description

Hemorrhoidal disease (HD) is the most common proctological condition, with an up to 86% prevalence (asymptomatic individuals underestimated). It is expected that 5% of the population might have at least one episode of HD during their lifetime, most individuals amenable to medical therapy but 10 to 20% of them requiring surgical intervention. HD has an occurrence peak between the 5th and 7th decades of life. Haemorrhoids can be defined as varicose dilatation of the submucosal anorectal veins due to persistently elevated venous pressure in the hemorrhoidal plexus, that is, they develop when the venous drainage of the anus and rectum is altered, causing dilatation of the venous plexus and connective tissue, creating an overgrowth of the anal mucosa of the rectal wall. The term HD is used when haemorrhoids cause symptoms. Aesculus hippocastanum (horse chestnut), rutin, Smilax papyracea (sarsaparilla), Polygonum acre (dotted smartweed) combination is commonly used to control chronic venous insufficiency (CVI) manifestations. Assuming pathophysiology of HD and CVI are similar, the investigators hypothesized the above combination could be also useful in the management of the former condition.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Grade 1, 2 or 3 hemorrhoidal disease
• Complaints related to haemorrhoidal disease/acute hemorrhoidal crisis (defined as acute anal pain due to haemorrhoidal prolapse with or without bleeding, edema and thrombosis)
• For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraception.
• Patient has read, understood, signed and dated the informed consent form

Exclusion criteria

• Presence of concomitant severe systemic disorders
• Treatment with venotonics within 2 months of the date of inclusion in the study
• Women of reproductive age who are pregnant or breastfeeding, or who do not wish to use contraception during the study period.
• Known allergy or hypersensitivity to any component of the study medication
• Known significant laboratory abnormality
• Anal fissure
• Inflammatory bowel disease
• Colorectal cancer
• Anal abscess or fistula
• Previous anorectal surgery and/or radiotherapy in the pelvic-perineal region
• Patient with a change in general condition that is incompatible with her participation in the study
• Patient who wishes to become pregnant within 6 months
• Inability of the patient to understand the nature of the study and follow the doctor's recommendations

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Aesculus hippocastanum, and interventions

Other group

Description:

Self-paired study

Treatment:

Drug: Aesculus hippocastanum, and interventions