[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643352":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":26,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"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],{"facility":5,"status":33,"city":34,"state":26,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Thessaloniki","54636","Greece","GR",{"type":39,"coordinates":40},"Point",[41,42],22.93493,40.64072,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"IOANNIS MYKONIATIS, Ass.Professor","CONTACT","6936975862","+30","g_mikoniatis@hotmail.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ioannis Mykoniatis","Ass.Professor","100643352","oxiblumecoq10-ralivia-therapy-for-benign-prostatic-hyperplasia-100643352",false,"NCT07638865","Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:","Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia: a Double-blind Placebo-controlled Randomized Clinical Trial Assessing Treatment Efficacy and Safety.","Inclusion Criteria:\n\n1. Participant must be between 50 and 80 years old.\n2. Participant has signed and dated the appropriate Informed Consent document.\n3. International Prostate Symptom Score (IPSS) ≥8 and ≤30\n4. Prostate volume ≥30gram and ≤80gram\n5. Peak urinary flow rate (Qmax) ≥5 ml\u002Fsec and ≤15ml\u002Fsec\n6. Post void residual volume ≤150ml\n\nExclusion Criteria:\n\n1. Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention.\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 (except from BPH) associated with LUTS, any neurological disease or disorder affecting the bladder.\n6. Participant has undergone prostate surgery\n7. Participant with penile or urinary sphincter implants.\n8. Diagnosed neurological conditions known to affect bladder function (e.g., multiple sclerosis, Parkinson's disease, or neurogenic bladder).\n9. Significant medical conditions (e.g., unstable cardiac arrhythmias, uncontrolled diabetes, severe renal impairment) that pose an unreasonable risk to the patient or might interfere with study results.\n10. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.\n11. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.","MALE","50 Years","80 Years",{"count":66,"type":67},100,"ESTIMATED","INTERVENTIONAL",[70],"NA","Objectives of the study\n\nThe aim of the study is to investigate and compare the treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy vs placebo for BPH patients\n\nStudy center\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 BPH 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 BPH diagnosis will participate in this study.\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 of BPH patients.\n\n(H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment of BPH patients.\n\nStudy endpoints Primary endpoint: The difference between the Group A and Group B in the change of IPSS 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 IPSS score from baseline to 6 weeks after treatment initiation.\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. Qmax value\n  2. Prostate volume\n  3. Post void residual\n  4. IIEF-ED score\n  5. Psa value\n  6. TNFa, IL 6 values\n\nTreatment Visits :\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 IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported.\n\nPSA TNFa, IL 1β, IL 6, IL 10 will be measured through blood test.\n\nFU Visit 2: 12 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported.\n\nDRE will be performed . PSA TNFa, IL 6 will be measured through blood test.",[73,74,75],"Benign Prostate Enlargement","Benign Prostate Hypertrophy(BPH)","Benign Prostate Obstruction (BPO)","2026-06-04",{"date":78,"type":79},"2026-06-10","ACTUAL",{"date":81,"type":67},"2026-06-08",{"date":83,"type":67},"2026-12",{"name":5,"class":6},1]