[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637276":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":55,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"G.Gennimatas General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","ACTIVE_COMPARATOR","Patients of the Active Group will receive 1 pill of Ralivia per os\u002Fday for a 3-month period",[13],"Dietary Supplement: Oxiblume:CoQ10 (Ralivia) therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","PLACEBO_COMPARATOR","Patients of the Placebo Group will receive 1 placebo pill per os\u002Fday for a 3-month period",[19],"Other: Placebo Pill.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Oxiblume:CoQ10 (Ralivia) therapy","1 pill of Ralivia per os\u002Fday for a 3-month period",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Pill.","1 placebo pill per os\u002Fday for a 3-month period",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"IOANNIS MYKONIATIS, Professor","CONTACT","+306936975862","+30","g_mikoniatis@hotmail.com",[39],{"facility":5,"status":40,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Thessaloniki","54636","Greece","GR",{"type":46,"coordinates":47},"Point",[48,49],22.93493,40.64072,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":36,"email":37},"IOANNIS MYKONIATIS, professor","6936975862",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ioannis Mykoniatis","Ass.Professor","100637276","oxiblumecoq10-ralivia-therapy-for-chronic-prostatitischronic-pelvic-pain-syndrome-cpcpps-100637276",false,"NCT07629505","Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS)","Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS): a Double-blind Placebo-controlled Randomized Clinical Trial Assessing Treatment Efficacy and Safety.","Inclusion Criteria:\n\n1. Participant must be between 18 and 50 years old.\n2. Participant has signed and dated the appropriate Informed Consent document.\n3. Participant has had a clinical diagnosis of CP\u002FCPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months.\n\nExclusion Criteria:\n\n1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU\u002Fml in mid-stream urine (VB2).\n2. Participant has a history of prostate, bladder or urethral cancer.\n3. Participant has undergone pelvic radiation or systemic chemotherapy.\n4. Participant has undergone intravesical chemotherapy.\n5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.\n6. Participant has undergone prostate surgery or treatment.\n7. Participant with penile or urinary sphincter implants.\n8. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.\n9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.","MALE","18 Years","50 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"NA","Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS) has a huge socioeconomic impact.Presently, a ''scientific dead-end'' regarding effective treatment of CP\u002FCPPS is reported. Promising results of clinical studies, regardless their limitations, upon efficacy of phytotherapy for CP\u002FCPPS patients have been published .Phytotherapy is cost effective and avoids the systemic side effects of other treatments being a therapy with the possibility of repeating the treatment protocol at any time. Certain important issues, regarding the efficacy and safety of phytotherapy, remain to be answered thus investing scientifically and economically to the concept of phytotherapy for CP\u002FCPPS, definitively seems to be a move to the right direction.\n\nIn this concept we will conduct a double-blind placebo-controlled randomized clinical trial assessing treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy for CP\u002FCPPS\n\nThe study will be coordinated by the research office of 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. The research office will also support the project (logistics, quality control, management, data acquisition, publications).\n\nPatients visits will be carried out in the CP\u002FCPPS Research Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece.\n\nLaboratory tests of all patients will be performed at the same microbiology laboratory.\n\nStudy population A total of 100 patients (50 in Group A and 50 in Group B) with CP\u002FCPPS diagnosis will participate in this study.\n\nInclusion and exclusion criteria\n\nInclusion criteria:\n\n1. Participant must be between 18 and 50 years old.\n2. Participant has signed and dated the appropriate Informed Consent document.\n3. Participant has had a clinical diagnosis of CP\u002FCPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months.\n\nExclusion criteria:\n\n1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU\u002Fml in mid-stream urine (VB2).\n2. Participant has a history of prostate, bladder or urethral cancer.\n3. Participant has undergone pelvic radiation or systemic chemotherapy.\n4. Participant has undergone intravesical chemotherapy.\n5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.\n6. Participant has undergone prostate surgery or treatment.\n7. Participant with penile or urinary sphincter implants.\n8. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.\n9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.\n\nStudy design Double-blind placebo-controlled randomized clinical trial\n\nZero hypothesis (H0) and alternative hypothesis (H1):\n\n(H0): Group A demonstrates similar efficacy compared to Group B for the treatment CP\u002FCPPS patients.\n\n(H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment CP\u002FCPPS patients.\n\nStudy endpoints Primary endpoint: The difference between the Group A and Group B in the change of the pain domain of NIH-CPSI score from baseline to 12 weeks after treatment initiation.\n\nSecondary endpoints:\n\n* Adverse events rate in all patients during study period.\n* The difference between the Group A and Group B in the change of the pain domain of NIH-CPSI score from baseline to 6 weeks after treatment start.\n* The difference between the Group A and Group B in the change of the following parameters from baseline to 6 and 12 weeks after treatment initiation\n\n  1. Total NIH-CPSI score (Q1-9)\n  2. Urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score\n  3. IIEF-ED score\n  4. IPSS\n  5. UPPOINTS phenotype- number of positive domains\n  6. Psa value\n  7. TNFa, IL 6 values\n\nPatients accordingly to which group they will be randomized will receive:\n\n* Active treatment (Ralivia) Group : 1 pill of Ralivia per os\u002Fday for a 3-month period\n* Placebo Group : 1 placebo pill per os\u002Fday for a 3-month period\n\nAdverse events will be reported.\n\nFU Visit 1: 6 weeks after treatment initiation NIH-CPSI, IPSS, IIEF-ED questionnaires will be answered. Adverse events will be reported. Clinical symptoms assessed, in order to determine UPOINT status.\n\nPSA TNFa, IL 1β, IL 6, IL 10 blood test.\n\nFU Visit 2: 12 weeks after treatment initiation NIH-CPSI, IPSS, IIEF-ED questionnaires will be answered. Adverse events will be reported. Clinical symptoms assessed, in order to determine UPOINT status.\n\nDRE will be performed . PSA TNFa, IL 6 blood test",[77],"Chronic Pelvic Pain Syndrome (CPPS)","2026-06-01",{"date":80,"type":81},"2026-06-05","ACTUAL",{"date":83,"type":71},"2026-06-08",{"date":85,"type":71},"2026-12",{"name":5,"class":6},1]