ORal Aminaphtone and Combined LidocainE

Recruiting now

Conditions studied: Hemorrhoid

In brief

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.

Key facts

Study ID

NCT07026513

Run by

Treviso Regional Hospital

People needed

50

Starts

2025-05-08

Expected to finish

2025-07-31

Last updated by the study team

2025-06-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 to 85 years
• Diagnosis of symptomatic internal hemorrhoidal disease (Grade I-IV, Goligher classification)
• First outpatient consultation for current symptoms
• Written informed consent provided

You may not qualify if…

• Active proctologic conditions (e.g., anal fissures, fistulas, condylomas, neoplasms)
• Inflammatory bowel disease (IBD)
• Known HIV infection
• Previous surgical treatment for hemorrhoidal disease (except outpatient procedures performed >6 months prior)
• Current use of psychotropic, antibiotic, antifungal, immunomodulatory, or corticosteroid drugs
• Known hypersensitivity to Capillarema® or Octosedan® components

Where it is running

• Regional Hospital Treviso — Treviso, Italy (enrolling)

Full record on ClinicalTrials.gov

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