[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646902":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":60,"collaborators":20,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"S&R Farmaceutici S.p.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospidol","EXPERIMENTAL","patients enrolled in this arm will take 1 Prospidol suppository per day, to be administered before going to bed for 10 days each month, for a total period of 3 months",[13],"Device: Prospidol suppository",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Prospidol suppository","Prospidol is a medical device containing sodium hyaluronate, Boswellia serrata extract (65% boswellic acid), mallow extract, rice bran oil and Eugenia caryophyllus essential oil. The recommended dosage is: 1 suppository per day, to be taken before bedtime, for 10 days a month, for 3 months.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Rossana G Iannitti, PhD","CONTACT","+390758012764","r.iannitti@srfarmaceutici.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Giada Ceccarelli, PhD","0758012764","g.ceccarelli@srfarmaceutici.com",[32,50],{"facility":33,"status":34,"city":35,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"San Giuseppe Moscati Hospital","RECRUITING","Avellino","83100","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],14.79103,40.91494,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":48,"phoneExt":20,"email":49},"Antonio Di Girolamo, MD","+393491122060","antonio.digirolamo@hotmail.it",{"facility":51,"status":52,"city":53,"state":53,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":20},"Papa Giovanni XXIII Hospital","ACTIVE_NOT_RECRUITING","Bergamo","24127",{"type":40,"coordinates":56},[57,58],9.66721,45.69601,{"lat":58,"lon":57},{"type":61,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100646902","clinical-evaluation-of-the-efficacy-and-safety-of-a-medical-device-in-the-form-of-rectal-suppositories-prospidol-for-the-treatment-of-symptoms-associated-with-chronic-prostatitischronic-pelvic-pain-syndrome-100646902",false,"NCT07685847","Clinical Evaluation of the Efficacy and Safety of a Medical Device in the Form of Rectal Suppositories (Prospidol®) for the Treatment of Symptoms Associated With Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome.","Inclusion Criteria:\n\n* male subjects aged between 18 and 60;\n* clinical presentation typical of prostatitis and a clinical diagnosis of chronic prostatitis type IIIa or IIIb (CP\u002FCPPS) for at least 3 months;\n* no treatment for at least 2 months;\n* PSA \\\u003C 3 ng\u002FmL;\n* digital rectal examination negative for nodules or BPH;\n* negative microbiological tests on urine and seminal fluid;\n* baseline score on the validated Italian version of the NIH-CPSI pain domain questionnaire \\> 7 or total NIH-CPSI score \\> 15;\n* digital rectal examination not suggestive of prostate cancer.\n\nExclusion Criteria:\n\n* patients with signs of infection and a PSA level \\> 3 ng\u002Fml;\n* other active prostate conditions;\n* patients with active neoplastic, neurodegenerative or immunological conditions, those who are immunocompromised, or those who are already taking supplements or functional foods for any reason;\n* patients undergoing treatment with systemic or topical corticosteroids;\n* patients who will not sign the informed consent form;\n* patients unable to participate in a clinical trial for any reason (e.g. psychiatric patients, those with cancer, on dialysis, or with severe liver or kidney failure);\n* patients with allergies to any of the components of the medical device (MD) under investigation.","MALE","18 Years","60 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to evaluate whether a medical device is effective and safe in treating chronic prostatitis\u002Fchronic pelvic pain syndrome (CP\u002FCPPS) in adult men.\n\nThe main questions it aims to answer are:\n\n* Does the treatment reduce pain symptoms (measured by NIH-CPSI score) by more than 30% after one month?\n* Does the treatment improve urinary symptoms, quality of life, and sexual function?\n* What adverse events or side effects occur during treatment? Researchers will conduct a multicenter, open-label study involving 40 participants diagnosed with CP\u002FCPPS. All participants will receive the same treatment, and their outcomes will be monitored over time.\n\nParticipants will:\n\nUse one suppository daily for 10 days each month for 3 months Attend clinical visits at the start of the study and after 30, 60, and 90 days Complete validated questionnaires (NIH-CPSI, IPSS, SF-36, IIEF) at each visit Report any side effects or symptoms throughout the study At the end of the study, researchers will analyze symptom improvement, quality of life changes, and treatment tolerability.",[79],"Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS)",[81,82,83,84],"prostate","prostatitis","suppository","CP\u002FCPPS","2026-06-29",{"date":87,"type":88},"2026-07-06","ACTUAL",{"date":90,"type":88},"2025-09-01",{"date":92,"type":73},"2026-09",{"name":5,"class":6},2]