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

Fundação Educacional Serra dos Órgãos120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Haemorrhoidal Disease

Interventions

Aesculus hippocastanum, and interventionsDRUG

venotonic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

Hemorrhoidal Disease Symptom Score (HDSS) (adapted)

4 questions: 1. How often do you feel pain because of your hemorrhoids? 2. How often do you experience itching or discomfort in your anus? 3. How often do you bleed when you have a bowel movement? 4. How often do you soil your underwear (anal soil)? Possible answers: * Never * Less than once a month * Less than once a week * 1 to 6 days a week * Every day (always)

Time frame: 2 months

Short Health Scale HD (SHSHD)

1. In your opinion, how severe are your symptoms caused by hemorrhoids? 2. Do your symptoms interfere with your daily activities? 3. Are your symptoms causing you a lot of concern? 4. How is your overall sense of well-being? Possible answers: * 1 * 2 * 3 * 4 * 5

Time frame: 2 months

Secondary Outcomes

global satisfaction of the patient

Please indicate your overall satisfaction with the effectiveness of your treatment to date on the scale below: * Bad * Acceptable * Good * Very Good

Time frame: 3 months

global satisfaction of the physician

Please indicate your overall satisfaction with the effectiveness of your treatment to date on the scale below: * Bad * Acceptable * Good * Very Good

Time frame: 3 months

Data from ClinicalTrials.gov

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