Observational Study on the Effectiveness of a First-line Therapy With Aminaphtone and Lidocaine Cream in Patients With Hemorrhoidal Disease: a Prospective Monocentric Cohort Study

What this Trial Is About

Researchers are evaluating the effectiveness of a first-line treatment combining oral aminaphtone (Capillarema4) and a topical lidocaine cream (Octosedan4) for patients with symptomatic internal hemorrhoidal disease. This condition causes symptoms like bleeding, itching, discomfort, and swelling around the anus, affecting quality of life. The study compares this combination to standard conservative care, including diet advice and optional use of creams, in a real-world hospital setting in Italy. The study involves two groups: one receiving aminaphtone tablets three times daily for 7 days then twice daily for 3 weeks plus lidocaine cream applied at least twice daily or as needed, and a control group receiving dietary and hydration advice with optional lidocaine and emollient creams. Each patient's participation lasts 30 days. The study is observational and non-randomized with consecutive enrollment of about 50 adult patients divided evenly between the two groups. Participants will have their hemorrhoidal symptoms measured using the Hemorrhoidal Disease Symptom Score (HDSS) at the start and after 30 days. Quality of life will also be assessed with a specific questionnaire (SHS-HD). Researchers will monitor treatment tolerability based on patient reports and clinical assessments. Data are collected securely and analyzed to compare symptom changes and side effects between the two groups throughout the 30-day study period.

ORal Aminaphtone and Combined LidocainE