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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Regional Hospital Treviso
RECRUITING
Treviso
Contact Information
Primary
Ugo Grossi, PhD
ugo.grossi@aulss2.veneto.it
+39-3291649443
Time Frame
Start Date: 2025-05-08
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 50
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Treviso Regional Hospital

This content was sourced from clinicaltrials.gov