Oral aminaphtone plus topical lidocaine for internal hemorrhoids

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

This study will try an oral aminaphtone pill together with a lidocaine cream to reduce symptoms in adults with internal hemorrhoids compared with standard conservative care.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Treviso Regional Hospital (Research network)
• Locations: 1 site (Treviso)
• Trial ID: NCT07026513 on ClinicalTrials.gov

What this trial studies

ORACLE is a prospective, single-center observational study at Treviso Regional Hospital enrolling adults with symptomatic internal hemorrhoidal disease (Goligher I–IV). Patients in routine outpatient care will receive either oral aminaphtone (Capillarema®) combined with a topical lidocaine cream (Octosedan®) or standard advice on diet and hydration with optional topical emollients and lidocaine. Investigators will follow participants for 30 days to record symptom changes, tolerability, and any need for additional treatments using clinical assessments and patient-reported outcomes. The design captures real-world effectiveness and safety rather than results from a randomized trial.

Who should consider this trial

Good fit: Adults aged 18–85 with symptomatic internal hemorrhoidal disease (Goligher grades I–IV) presenting for their first outpatient consultation for the current symptoms who can give written informed consent.

Not a fit: Patients with active proctologic conditions (fissures, fistulas, condylomas, neoplasms), inflammatory bowel disease, known HIV infection, recent hemorrhoidal surgery, current immunomodulatory/corticosteroid/antibiotic/antifungal/psychotropic therapy, or known allergy to Capillarema® or Octosedan® components are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the combination could reduce bleeding and pain and improve quality of life, offering a more effective first-line conservative option and potentially lowering the need for procedural interventions.

How similar studies have performed: Aminaphtone has shown benefit in chronic venous and microvascular conditions and topical lidocaine is established for anal pain, but their combined use for hemorrhoidal disease is novel with limited direct evidence.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Treviso

• Regional Hospital Treviso — Treviso, Italy (Recruiting)

Study contacts

• Study coordinator: Ugo Grossi, PhD

Conditions Hemorrhoid