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Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease

Recruitingn/aAges 18 Years - 75 YearsAllCardarelli Hospital
NCT07295886 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to evaluate the effectiveness of topical nifedipine 0.3% plus lidocaine 1.5% for uncomplicated hemorrhoidal disease. The main question it aims to answer is: Does topical nifedipine 0.3% plus lidocaine 1.5% lower symptoms in patients with uncomplicated acute hemorrhoidal disease? Participants already taking nifedipine 0.3% plus lidocaine 1.5% as part of their regular medical care for hemorrhoidal disease will undergo four visits over a 30-day period, including two telephone contacts and two in-person visits.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male and female patients aged 18-75 years. * Clinical or anoscopic diagnosis of acute hemorrhoidal disease with prolapse severity between Grade II and IV (Goligher), possibly associated with external congestion. * Patients who started treatment with nifedipine 0.3% + lidocaine 1.5% within the past 5 days. * Availability of clinical evaluations at treatment initiation (proctologic visit and HDSS, SHS-HD, VAS scales). * Ability to understand the informed consent. * Signed informed consent. Exclusion Criteria: * Acute hemorrhoidal disease complicated by thrombosis or strangulation. * Coagulopathies. * Active neoplastic disease. * Treatment with anticoagulants and/or chemotherapeutic agents. * Hypersensitivity to active substances, especially lidocaine (and other amide-type local anesthetics) or excipients. * Severe hypotensive states or cardiovascular insufficiency. * Pregnancy or breastfeeding. * Participation in clinical trials involving investigational drugs.
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What it tests

  • topical nifedipine 0.3% plus lidocaine 1.5%
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Where

1 site
Azienda Ospedaliera "Antonio Cardarelli", Napoli
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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