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

4. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Grækenland
      • Thessaloniki, Grækenland, 54636
        • Rekruttering
        • G.Gennimatas General Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group A
Patients of the Active Group will receive 1 pill of Ralivia per os/day for a 3-month period
Kosttilskud: Oxiblume:CoQ10 (Ralivia) therapy
1 pill of Ralivia per os/day for a 3-month period
Placebo komparator: Group B
Patients of the Placebo Group will receive 1 placebo pill per os/day for a 3-month period
Andet: Placebo Pill.
1 placebo pill per os/day for a 3-month period

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The difference between the Group A and Group B in the change of IPSS score at 12 weeks after treatment initiation.
Tidsramme: "From enrollment to 12 weeks after treatment initiation "
"From enrollment to 12 weeks after treatment initiation "

Sekundære resultatmål

Resultatmål
Tidsramme
The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: From enrollment to 6 and 12 weeks
From enrollment to 6 and 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

G.Gennimatas General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

8. juni 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Ralivia_BPH- 22/5/26

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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