ORal Aminaphtone and Combined LidocainE

NCT07026513 | Recruiting

• 1 other identifier: ORACLE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhoid

Outcome Measures

Primary Outcomes (1)

• HDSS

  Change in Hemorrhoidal Disease Symptom Score (HDSS) from baseline to Day 30. The HDSS is a validated tool that assesses the severity of five key symptoms of hemorrhoidal disease: pain, bleeding, itching, soiling, and prolapse. Scores range from 0 to 20.

  From baseline (Day 0) to Day 30

Study Arms (2)

Treatment - Aminaphtone + Lidocaine

Patients in this cohort receive a combination therapy with oral aminaphtone (Capillarema®: 1 tablet TID for 7 days, then BID for 3 weeks) and topical lidocaine cream (Octosedan®: at least twice daily or as needed) for 30 days. The goal is to assess symptom relief and tolerability of the combination as a first-line treatment for internal hemorrhoidal disease (Grade I-IV).

Control - Standard Conservative Therapy

Patients in this cohort receive dietary and behavioral advice, including daily fiber intake (20-30 g/day) and hydration (≥1.5 L/day). They may also use topical Octosedan® and emollient creams as needed. This group represents guideline-based conservative management for symptomatic internal hemorrhoidal disease (Grade I-IV).

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18-85 years) referred to the proctology clinic of Treviso Regional Hospital for a first evaluation of symptomatic internal hemorrhoids (Grades I-IV). Patients are consecutively enrolled in two non-randomized cohorts and represent a real-world outpatient population eligible for conservative treatment.

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

Sponsors & Collaborators

• Treviso Regional Hospital: lead

Study Sites (1)

Regional Hospital Treviso

Treviso, 31100, Italy

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ugo Grossi, PhD

CONTACT

+39-3291649443; ugo.grossi@aulss2.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: May 8, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 31, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)