An observational study in Hemorrhoid, sponsored by Treviso Regional Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by Treviso Regional Hospital · Observational
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:
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.
Detailed Description
The ORACLE study (ORal Aminaphtone and Combined LidocainE) is a prospective, monocentric, observational study designed to assess the real-world effectiveness and tolerability of a first-line therapy with aminaphtone (Capillarema®) and lidocaine cream (Octosedan®) in patients with symptomatic internal hemorrhoidal disease (HD). The study is conducted in a tertiary care hospital setting in Treviso, Italy.
Study Rationale
Hemorrhoidal disease affects up to 39% of the population, particularly between ages 45 and 65. Symptoms such as bleeding, anal pain, prolapse, and perianal swelling often result from vascular congestion and local inflammation. While conservative treatments including fiber intake and topical agents are frequently used, a substantial proportion of patients report persistent or recurrent symptoms.
Aminaphtone is a synthetic drug with well-documented endothelial-stabilizing and anti-inflammatory properties. It has been successfully used in the management of chronic venous insufficiency, diabetic microangiopathy, and Raynaud's phenomenon. Its mechanisms include modulation of adhesion molecules (e.g., VCAM-1, ICAM-1), pro-inflammatory cytokines (e.g., IL-6, VEGF, TGF-β), and vasoactive substances (e.g., endothelin-1). Given the similarities in vascular pathophysiology between hemorrhoidal disease and other chronic venous conditions, aminaphtone may offer therapeutic benefits in the hemorrhoidal setting.
Lidocaine, a well-established local anesthetic, is widely used for symptomatic relief in HD. The topical formulation (Octosedan®) included in this study is part of the standard conservative regimen in Italy.
Currently, there are no prospective studies evaluating the effectiveness of this combined regimen. The ORACLE study addresses this gap by comparing the combination therapy to standard conservative treatment in a real-world setting.
Study Design
This is a controlled, non-randomized, two-cohort study:
Participants will be enrolled in two consecutive time windows, with temporal allocation to either cohort. The duration of each participant's involvement is 30 days.
Inclusion Criteria
Exclusion Criteria
Interventions
Treatment Group:
Control Group:
Notably, the control arm does not include a placebo, as the conservative measures represent guideline-based first-line therapy per the Italian Society of Colorectal Surgery (SICCR).
Outcomes
Primary Endpoint:
Secondary Endpoints:
Sample Size
A total of 50 patients will be enrolled, 25 per cohort. This sample size assumes:
Data Collection and Bias Mitigation
Data will be recorded using paper case report forms and transferred into a secure, anonymized database. To minimize bias, the follow-up visit will be performed by an investigator different from the one who conducted the baseline assessment.
Statistical Analysis
Primary analysis will follow both intention-to-treat and per-protocol principles. Statistical tests include:
Safety and Adverse Events
Adverse events (AEs) and serious adverse events (SAEs) will be recorded per ISO14155 guidelines, including severity and causal relationship with treatment.
Severity will be classified as:
Causality terms:
Ethical and Regulatory Considerations
The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines (Ministerial Decree 15.07.97). Approval from the local Ethics Committee is required before study initiation. Written informed consent is mandatory.
Sponsorship and Conflict of Interest
This study is supported by an unrestricted grant from Laboratori Baldacci S.p.A., the manufacturer of Capillarema® and Octosedan®. The sponsor is not involved in study design, data analysis, or publication decisions.
Dissemination Plan
Findings from this study will be submitted for publication in peer-reviewed journals and presented at relevant scientific conferences. Trial results will also be updated on ClinicalTrials.gov in compliance with reporting requirements.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 50 is below the median of 151 across 49 observational studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Treviso Regional Hospital is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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).
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.
Time frame: From baseline (Day 0) to Day 30
Plan to share: No — Individual participant data (IPD) will not be shared due to the monocentric nature of the study, the small sample size, and the absence of a data sharing infrastructure. Additionally, the informed consent obtained from participants does not include provisions for sharing anonymized data with external researchers. Any future data sharing would require a protocol amendment and additional ethics approval.
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Jul 2025, 2 months after the start.
Of 27 observational studies under Hemorrhoids, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
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Treviso Regional Hospital