Recent Advances in Clinical Trials
Open AccessEfficacy of Aesculus hippocastanum (Horse Chestnut) and Combination Therapies in Improving Clinical Outcomes of Hemorrhoidal Disease: A 60- Day Prospective Controlled Trial
Authors: Rzetelna Hélio, Nunes Carlos P, Lopes Gabriela Juncá TP, Steinbruch Marcio, Gama Carlos Romualdo B, Suchmacher Mendel, Kaufman Renato, Nigri Rafael, Sitnoveter Aline Levy, Daher João Paulo L, Mezitis Spyros, Geller Mauro.
Abstract
Background: Hemorrhoids are prevalent, affecting up to 39% of adults, with venous wall failure as a key pathological factor. Limited pharmacological options target this mechanism, necessitating novel therapies.
Objective: To evaluate the safety and efficacy of Aesculus hippocastanum combined with Polygonum punctatum, Smilax papyracea, and rutin over 60 days in managing symptoms of Grade I–III hemorrhoids.
Methods: In a self-controlled design, 120 participants were assessed at baseline (Visit 1) and Day 60 (Visit 2) using the visual analogue scale (VAS), hemorrhoidal disease symptom score (HDSS), adapted Short Health Scale, physician and patient assessment scores, ease of swallowing, adherence, and safety monitoring.
Results: Significant improvements (p<0.05) were observed in all efficacy endpoints at Visit 2, with no grade differences and near100% adherence. The combination was well-tolerated.
Conclusion: This 60-day regimen appears safe and effective for hemorrhoid symptom relief, independent of severity grade, with high swallowability potentially aiding adherence. ClinicalTrials.gov: NCT06705777.
Editor-in-Chief
View full editorial board →