Benign Prostate EnlargementNCT07638865
Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:
A study testing Oxiblume:CoQ10 (Ralivia) therapy in people with Benign Prostate Enlargement and Benign Prostate Hypertrophy(BPH), run by G.Gennimatas General Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostate Enlargement, Benign Prostate Hypertrophy(BPH), Benign Prostate Obstruction (BPO)
- What is being tested?
- Oxiblume:CoQ10 (Ralivia) therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 8 Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be between 50 and 80 years old.
- Participant has signed and dated the appropriate Informed Consent document.
- International Prostate Symptom Score (IPSS) ≥8 and ≤30
- Prostate volume ≥30gram and ≤80gram
- Peak urinary flow rate (Qmax) ≥5 ml/sec and ≤15ml/sec
- Post void residual volume ≤150ml
Who cannot join
- Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention.
- 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 (except from BPH) associated with LUTS, any neurological disease or disorder affecting the bladder.
- Participant has undergone prostate surgery
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- Participant with penile or urinary sphincter implants.
- Diagnosed neurological conditions known to affect bladder function (e.g., multiple sclerosis, Parkinson's disease, or neurogenic bladder).
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
G.Gennimatas General Hospital
Thessaloniki, 54636
IOANNIS MYKONIATIS, Ass.Professor, 6936975862 ext. +30, g_mikoniatis@hotmail.com
About this study
Official title: 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
Read more
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
- Qmax value
- Prostate volume
- Post void residual
- IIEF-ED score
- Psa value
- 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)
- Being tested
- Oxiblume:CoQ10 (Ralivia) therapy, Placebo Pill.
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxiblume:CoQ10 (Ralivia) therapyDietary supplement
1 pill of Ralivia per os/day for a 3-month period
Placebo Pill.Other
1 placebo pill per os/day for a 3-month period
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients of the Active Group will receive 1 pill of Ralivia per os/day for a 3-month period Receives: Dietary Supplement: Oxiblume:CoQ10 (Ralivia) therapy |
| Group B | Placebo comparator | Patients of the Placebo Group will receive 1 placebo pill per os/day for a 3-month period Receives: Other: Placebo Pill. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the Group A and Group B in the change of IPSS score at 12 weeks after treatment initiation.
Measured: "From enrollment to 12 weeks after treatment initiation "
Secondary outcomes (7)
The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start8 Jun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate EnlargementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Mykoniatis, G.Gennimatas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638865
- Sponsor's protocol ID
- Ralivia_BPH- 22/5/26
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia: a Double-blind Placebo-controlled Randomized Clinical Trial Assessing Treatment Efficacy and Safety.
- ClinicalTrials.gov ID
- NCT07638865
- Acronym / sponsor ID
- Ralivia_BPH- 22/5/26
- Conditions
- Benign Prostate Enlargement, Benign Prostate Hypertrophy(BPH), Benign Prostate Obstruction (BPO)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Study start
- 8 Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Qmax value
- Prostate volume
- Post void residual
- IIEF-ED score
- Psa value
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Dietary Supplement: Oxiblume:CoQ10 (Ralivia) therapyPatients of the Active Group will receive 1 pill of Ralivia per os/day for a 3-month period |
| Group B | Placebo comparator | Other: Placebo Pill.Patients of the Placebo Group will receive 1 placebo pill per os/day for a 3-month period |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be between 50 and 80 years old.
- Participant has signed and dated the appropriate Informed Consent document.
- International Prostate Symptom Score (IPSS) ≥8 and ≤30
- Prostate volume ≥30gram and ≤80gram
- Peak urinary flow rate (Qmax) ≥5 ml/sec and ≤15ml/sec
Key exclusion criteria (11 listed)
- Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention.
- 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 (except from BPH) associated with LUTS, any neurological disease or disorder affecting the bladder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxiblume:CoQ10 (Ralivia) therapy1 pill of Ralivia per os/day for a 3-month period | Dietary supplement | Group A |
| Placebo Pill.1 placebo pill per os/day for a 3-month period | Other | Group B |
Primary outcome
The difference between the Group A and Group B in the change of IPSS score at 12 weeks after treatment initiation.
Time frame: "From enrollment to 12 weeks after treatment initiation "
7 secondary outcomes
The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to 6 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxiblume:CoQ10 (Ralivia) therapy in people with Benign Prostate Enlargement and Benign Prostate Hypertrophy(BPH), run by G.Gennimatas General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the Group A and Group B in the change of IPSS score at 12 weeks after treatment initiation. (time frame: "From enrollment to 12 weeks after treatment initiation "). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.