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Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:

4 de junio de 2026 actualizado por: Ioannis Mykoniatis, G.Gennimatas General Hospital

Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia: a Double-blind Placebo-controlled Randomized Clinical Trial Assessing Treatment Efficacy and Safety.

Objectives of the study

The aim of the study is to investigate and compare the treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy vs placebo for BPH patients

Study center

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 BPH 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 BPH diagnosis will participate in this study.

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 of BPH patients.

(H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment of BPH patients.

Study 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.

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 IPSS score from baseline to 6 weeks after treatment initiation.

  • 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. Qmax value
    2. Prostate volume
    3. Post void residual
    4. IIEF-ED score
    5. Psa value
    6. TNFa, IL 6 values

Treatment Visits :

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 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.

PSA TNFa, IL 1β, IL 6, IL 10 will be measured through blood test.

FU 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.

DRE will be performed . PSA TNFa, IL 6 will be measured through blood test.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Grecia
      • Thessaloniki, Grecia, 54636
        • Reclutamiento
        • G.Gennimatas General Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Participant must be between 50 and 80 years old.
  2. Participant has signed and dated the appropriate Informed Consent document.
  3. International Prostate Symptom Score (IPSS) ≥8 and ≤30
  4. Prostate volume ≥30gram and ≤80gram
  5. Peak urinary flow rate (Qmax) ≥5 ml/sec and ≤15ml/sec
  6. Post void residual volume ≤150ml

Exclusion Criteria:

  1. Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention.
  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 (except from BPH) associated with LUTS, any neurological disease or disorder affecting the bladder.
  6. Participant has undergone prostate surgery
  7. Participant with penile or urinary sphincter implants.
  8. Diagnosed neurological conditions known to affect bladder function (e.g., multiple sclerosis, Parkinson's disease, or neurogenic bladder).
  9. 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.
  10. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.
  11. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Group A
Patients of the Active Group will receive 1 pill of Ralivia per os/day for a 3-month period
Suplemento dietético: Oxiblume:CoQ10 (Ralivia) therapy
1 pill of Ralivia per os/day for a 3-month period
Comparador de placebos: Group B
Patients of the Placebo Group will receive 1 placebo pill per os/day for a 3-month period
Otro: Placebo Pill.
1 placebo pill per os/day for a 3-month period

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
The difference between the Group A and Group B in the change of IPSS score at 12 weeks after treatment initiation.
Periodo de tiempo: "From enrollment to 12 weeks after treatment initiation "
"From enrollment to 12 weeks after treatment initiation "

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation.
Periodo de tiempo: From enrollment to 6 weeks
From enrollment to 6 weeks
The difference between the Group A and Group B in the change of Qmax value from baseline to 6 and 12 weeks after treatment initiation.
Periodo de tiempo: From enrollment to 6 and 12 weeks
From enrollment to 6 and 12 weeks
The difference between the Group A and Group B in the change of prostate volume from baseline to 6 and 12 weeks after treatment initiation.
Periodo de tiempo: From enrollment to 6 and 12 weeks
From enrollment to 6 and 12 weeks
The difference between the Group A and Group B in the change of post void residual (PVR) from baseline to 6 and 12 weeks after treatment initiation.
Periodo de tiempo: From enrollment to 6 and 12 weeks
From enrollment to 6 and 12 weeks
The difference between the Group A and Group B in the change of International Index of Erectile Function -Erectile Domaine (IIEF-ED) score from baseline to 6 and 12 weeks after treatment initiation.
Periodo de tiempo: From enrollment to 6 and 12 weeks
From enrollment to 6 and 12 weeks
The difference between the Group A and Group B in the change of PSA value from baseline to 6 and 12 weeks after treatment initiation.
Periodo de tiempo: From enrollment to 6 and 12 weeks
From enrollment to 6 and 12 weeks
The difference between the Group A and Group B in the change of TNFa and IL6 value from baseline to 6 and 12 weeks after treatment initiation.
Periodo de tiempo: From enrollment to 6 and 12 weeks
From enrollment to 6 and 12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

G.Gennimatas General Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

8 de junio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

4 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Ralivia_BPH- 22/5/26

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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