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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05306314
Other study ID # GMG.22.TRT.01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2022
Est. completion date October 15, 2023

Study information

Verified date February 2022
Source GMG Grand Medical
Contact Tuba Gun
Phone +905458101108
Email t.gun@gmgroup.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multicenter, Retrospectivecohort study in patients with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) and 140 patients without other significant comorbidities will be participated. The aim of the study is to collect post-treatment data to evaluate inflammation, infection status and quality of life with standard antibiotic therapy with NSAID and added Treataprost effect.


Description:

This study will be conducted in Patients with Confirmed Chronic Prostatitis and the datas of these patients will be recorded. In real clinical practice, the data of patients who received Treataprost in addition to antibiotic therapy with NSAIDs will be recorded. This is a non-invasive retrospective cohort study. The primary endpoint of this study is: - To determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) - Treataprost added to standard antibiotic therapy and NSAID in clinical practice, Chronic Prostatitis, Chronic in patients with Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) understanding treatment patterns The secondary endpoint of this study is: - The aim of the study will to evaluated gather detailed information about the effect on quality of life of Treataprost given with standard antibiotic therapy and NSAID. - It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID


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Study Design


Intervention

Dietary Supplement:
TREATAPROST
oral administration before meals 30 minutes

Locations

Country Name City State
Turkey 18 Mart University Faculty of Medicines Çanakkale
Turkey TR Ministry of Health Eskisehir City Hospital Eskisehir
Turkey Süleyman Demirel University Faculty of Medicines Isparta
Turkey Manisa Celal Bayar University Hafsa Sultan Hospital Manisa

Sponsors (2)

Lead Sponsor Collaborator
GMG Grand Medical Gama CRO Tibbi Ilaç Arastirma Org.Tic.Ltd.Sti

Country where clinical trial is conducted

Turkey, 

References & Publications (51)

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Outcome

Type Measure Description Time frame Safety issue
Primary To determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) Determining the relationship between the disease and collecting socio-demographic information such as age, education level, lifestyle once
Primary Treataprost added to standard antibiotic therapy and NSAID in clinical practice, Chronic Prostatitis, Chronic in patients with Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) understanding treatment patterns Collecting data on Treataprost treatment added to standard antibiotic treatment and NSAID in clinical practice once
Secondary The aim of the study will to evaluated gather detailed information about the effect on quality of life of Treataprost given with standard antibiotic therapy and NSAID. To collect gather detailed information qualirt of life after post treatment Once
Secondary • It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID To collect gather detailed information the infection status after post treatment once
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