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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HDSS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
HDSS
时间窗: 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.
次要结局
未报告次要终点