ORal Aminaphtone and Combined LidocainE

Condition(s) studied

Study 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

Primary outcome measure(s)

• HDSS — From baseline (Day 0) to Day 30
  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.

Trial sites (1)

Other trials for the same condition