Randomized Study of Oral Aesculus Hippocastanum and Combinations in Hemorrhoidal Disease After 60… (NCT06705777) | Clinical Trial Compass
CompletedPhase 4
Randomized Study of Oral Aesculus Hippocastanum and Combinations in Hemorrhoidal Disease After 60 Days of Treatment
Brazil120 participantsStarted 2024-09-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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