Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorCardarelli Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Acute hemorrhoidal disease complicated by thrombosis or strangulation.
Coagulopathies.
Active neoplastic disease.
Treatment with anticoagulants and/or chemotherapeutic agents.
Trial design
Treatments tested in this trial
- topical nifedipine 0.3% plus lidocaine 1.5%
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Cardarelli Hospital
Lead sponsor
Neopharmed Gentili S.p.A.
Collaborator
Source ClinicalTrials.gov