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

NCT07638865 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-10

No results posted yet for this study

Summary

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.

Conditions

  • Benign Prostate Enlargement
  • Benign Prostate Hypertrophy(BPH)
  • Benign Prostate Obstruction (BPO)

Interventions

DIETARY_SUPPLEMENT

Oxiblume:CoQ10 (Ralivia) therapy

1 pill of Ralivia per os/day for a 3-month period

OTHER

Placebo Pill.

1 placebo pill per os/day for a 3-month period

Sponsors & Collaborators

  • G.Gennimatas General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07638865 on ClinicalTrials.gov