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ORal Aminaphtone and Combined LidocainE

Study acronym: ORACLE
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated June 18, 2025 (before its estimated July 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
This observational study, called ORACLE (ORal Aminaphtone and Combined LidocainE), is being conducted at Treviso Regional Hospital (Italy) to evaluate the effectiveness of a first-line treatment for patients with internal hemorrhoidal disease (HD). The study focuses on a combination therapy using an oral drug, aminaphtone (Capillarema®), and a topical cream with lidocaine (Octosedan®), compared to standard conservative care. Hemorrhoidal disease is a common condition that can cause bleeding, discomfort, itching, and swelling in the anal area. Many patients experience symptoms that affect their quality of life, even when using standard treatments like fiber supplements and emollient creams. This study involves two groups of patients: * One group will receive oral aminaphtone (Capillarema®) plus lidocaine cream (Octosedan®). * The other group will receive standard advice on diet and hydration, along with optional use of lidocaine cream and emollients. Patients will be followed for 30 days. The main goal is to measure how much the combination treatment improves hemorrhoidal symptoms compared to the standard treatment. This will be assessed using a score called HDSS (Hemorrhoidal Disease Symptom Score). The study will also evaluate quality of life using a specific questionnaire (SHS-HD) and assess how well patients tolerate the treatment. About 50 adult patients will take part, divided into two consecutive groups of 25 each. The study does not involve random assignment or blinding. All participants will be informed about the study procedures and give written consent. The results of this study may help doctors better understand the role of aminaphtone in managing hemorrhoidal disease and could improve future treatment recommendations.
Trial Details
NCT Number NCT07026513
Lead Sponsor Treviso Regional Hospital
Conditions
(from sponsor)
Hemorrhoid
Related terms Hemorrhoids
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov