Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Официальное название

Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): a Double-blind Placebo-controlled Randomized Clinical Trial Assessing Treatment Efficacy and Safety.

Обзор

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) has a huge socioeconomic impact.Presently, a ''scientific dead-end'' regarding effective treatment of CP/CPPS is reported. Promising results of clinical studies, regardless their limitations, upon efficacy of phytotherapy for CP/CPPS 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/CPPS, definitively seems to be a move to the right direction. In 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/CPPS The 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). Patients visits will be carried out in the CP/CPPS Research Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. Laboratory tests of all patients will be performed at the same microbiology laboratory. Study population A total of 100 patients (50 in Group A and 50 in Group B) with CP/CPPS diagnosis will participate in this study. Inclusion and exclusion criteria Inclusion criteria: 1. Participant must be between 18 and 50 years old. 2. Participant has signed and dated the appropriate Informed Consent document. 3. Participant has had a clinical diagnosis of CP/CPPS 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. Exclusion criteria: 1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2). 2. Participant has a history of prostate, bladder or urethral cancer. 3. Participant has undergone pelvic radiation or systemic chemotherapy. 4. Participant has undergone intravesical chemotherapy. 5. 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. 6. Participant has undergone prostate surgery or treatment. 7. Participant with penile or urinary sphincter implants. 8. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis. 9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol. Study design Double-blind placebo-controlled randomized clinical trial Zero hypothesis (H0) and alternative hypothesis (H1): (H0): Group A demonstrates similar efficacy compared to Group B for the treatment CP/CPPS patients. (H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment CP/CPPS patients. Study 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. Secondary endpoints: * Adverse events rate in all patients during study period. * 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. * 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 1. Total NIH-CPSI score (Q1-9) 2. Urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score 3. IIEF-ED score 4. IPSS 5. UPPOINTS phenotype- number of positive domains 6. Psa value 7. TNFa, IL 6 values Patients accordingly to which group they will be randomized will receive: * Active treatment (Ralivia) Group : 1 pill of Ralivia per os/day for a 3-month period * Placebo Group : 1 placebo pill per os/day for a 3-month period Adverse events will be reported. FU 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. PSA TNFa, IL 1β, IL 6, IL 10 blood test. FU 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. DRE will be performed . PSA TNFa, IL 6 blood test

Вмешательства

• Пищевая добавка Oxiblume:CoQ10 (Ralivia) therapy
  1 pill of Ralivia per os/day for a 3-month period
• Другое Placebo Pill.
  1 placebo pill per os/day for a 3-month period

Первичные конечные точки

• The difference between the Group A and Group B in the change of the pain domain of National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score from baseline to 12 weeks [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (10)

• 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 [Срок оценки: From baseline to 6 weeks]
• The difference between the Group A and Group B in the change of Total NIH-CPSI score (Q1-9) from baseline to 6 and 12 weeks [Срок оценки: From baseline to 6 and 12 weeks]
• The difference between the Group A and Group B in the change of Urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score from baseline to 6 and 12 weeks [Срок оценки: From baseline to 6 and 12 weeks]
• The difference between the Group A and Group B in the change of International Index of Erectile Function -Erectile Domain (IIEF-ED ) score from baseline to 6 and 12 weeks [Срок оценки: From baseline to 6 and 12 weeks]
• The difference between the Group A and Group B in the change of International Prostate Symptom Score (IPSS) from baseline to 6 and 12 weeks [Срок оценки: From baseline to 6 and 12 weeks]
• The difference between the Group A and Group B in the change of UPPOINTS phenotype- number of positive domains from baseline to 6 and 12 weeks [Срок оценки: From baseline to 6 and 12 weeks]
• The difference between the Group A and Group B in the change of Prostatic Specific Antigen (PSA) from baseline to 6 and 12 weeks [Срок оценки: From baseline to 6 and 12 weeks]
• The difference between the Group A and Group B in the change of Interleukin -6 from baseline to 6 and 12 weeks [Срок оценки: From baseline to 6 and 12 weeks]
• The difference between the Group A and Group B in the change of TNFa from baseline to 6 and 12 weeks [Срок оценки: From baseline to 6 and 12 weeks]
• Any adverse event [Срок оценки: From baseline to 12 weeks]

Критерии участия

Критерии включения

• Participant must be between 18 and 50 years old.
• Participant has signed and dated the appropriate Informed Consent document.
• Participant has had a clinical diagnosis of CP/CPPS 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.

Критерии исключения

• Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
• Participant has a history of prostate, bladder or urethral cancer.
• Participant has undergone pelvic radiation or systemic chemotherapy.
• Participant has undergone intravesical chemotherapy.
• 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.
• Participant has undergone prostate surgery or treatment.
• Participant with penile or urinary sphincter implants.
• Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.
• Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Греция · 1 центр

• G.Gennimatas General Hospital — Thessaloniki

Идентификаторы

NCT: NCT07629505 · Ralivia_CPPS- 22/5/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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