Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:
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
- 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Thessaloniki, Řecko, 54636
- Nábor
- G.Gennimatas General Hospital
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Kontakt:
- IOANNIS MYKONIATIS, Ass.Professor
- Telefonní číslo: +30 6936975862
- E-mail: g_mikoniatis@hotmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Group A
Patients of the Active Group will receive 1 pill of Ralivia per os/day for a 3-month period
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1 pill of Ralivia per os/day for a 3-month period
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Komparátor placeba: Group B
Patients of the Placebo Group will receive 1 placebo pill per os/day for a 3-month period
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1 placebo pill per os/day for a 3-month period
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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The difference between the Group A and Group B in the change of IPSS score at 12 weeks after treatment initiation.
Časové okno: "From enrollment to 12 weeks after treatment initiation "
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"From enrollment to 12 weeks after treatment initiation "
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation.
Časové okno: From enrollment to 6 weeks
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From enrollment to 6 weeks
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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.
Časové okno: From enrollment to 6 and 12 weeks
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From enrollment to 6 and 12 weeks
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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.
Časové okno: From enrollment to 6 and 12 weeks
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From enrollment to 6 and 12 weeks
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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.
Časové okno: From enrollment to 6 and 12 weeks
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From enrollment to 6 and 12 weeks
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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.
Časové okno: From enrollment to 6 and 12 weeks
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From enrollment to 6 and 12 weeks
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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.
Časové okno: From enrollment to 6 and 12 weeks
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From enrollment to 6 and 12 weeks
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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.
Časové okno: From enrollment to 6 and 12 weeks
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From enrollment to 6 and 12 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Ralivia_BPH- 22/5/26
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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