[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemorrhoids-prolapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemorrhoids-prolapse":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100615690",false,"NCT07295886","Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease","Observational Study on the Use of Topical Nifedipine 0.3% and Lidocaine 1.5% in Acute Uncomplicated Hemorrhoidal Disease","NILOS","Inclusion Criteria:\n\n* Male and female patients aged 18-75 years.\n* Clinical or anoscopic diagnosis of acute hemorrhoidal disease with prolapse severity between Grade II and IV (Goligher), possibly associated with external congestion.\n* Patients who started treatment with nifedipine 0.3% + lidocaine 1.5% within the past 5 days.\n* Availability of clinical evaluations at treatment initiation (proctologic visit and HDSS, SHS-HD, VAS scales).\n* Ability to understand the informed consent.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Acute hemorrhoidal disease complicated by thrombosis or strangulation.\n* Coagulopathies.\n* Active neoplastic disease.\n* Treatment with anticoagulants and\u002For chemotherapeutic agents.\n* Hypersensitivity to active substances, especially lidocaine (and other amide-type local anesthetics) or excipients.\n* Severe hypotensive states or cardiovascular insufficiency.\n* Pregnancy or breastfeeding.\n* Participation in clinical trials involving investigational drugs.","ALL","18 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","30 Days","OBSERVATIONAL","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:\n\nDoes 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.",[26,27,28,29,30],"Hemorrhoid Bleeding","Hemorrhoids Prolapse","Hemorrhoid Pain","Hemorrhoid","Topical Administration",[32,33,34],"nifedipine 0.3% plus lidocaine 1.5%","uncomplicated hemorrhoidal disease","hemorrhoids symptoms","RECRUITING","2025-12-19",{"date":38,"type":39},"2025-12-22","ACTUAL",{"date":41,"type":39},"2025-09-02",{"date":43,"type":21},"2026-05-02",{"name":45,"class":46},"Cardarelli Hospital","OTHER",""]