Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000888763
Ethics application status
Approved
Date submitted
1/08/2013
Date registered
8/08/2013
Date last updated
1/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of the effect of Serenoa Repens on prostatic inflammation
Scientific title
Does treatment with Serenoa Repens results in improvement of inflammation score compared to no treatment, in men with histologically prostatic inflammation?
Secondary ID [1] 282941 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic inflammation 289763 0
Condition category
Condition code
Alternative and Complementary Medicine 290101 290101 0 0
Herbal remedies
Renal and Urogenital 290102 290102 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with prostatic inflammation based on biopsy result are randomized to receive either Serenoa Repens (oral capsules for 6 months) 320mg daily (Group 1) or no treatment (Group 2). Monitoring will be based on patients' tablet return.
Intervention code [1] 287645 0
Treatment: Other
Comparator / control treatment
Active, no treatment
Control group
Active

Outcomes
Primary outcome [1] 290142 0
Inflammation score (Irani et al 1997)
Timepoint [1] 290142 0
Six months after intervention
Secondary outcome [1] 304009 0
Immunohistochemical study of inflammation
- CD3, CD4, CD8 T-lymphocytes
- CD20 B-lymphocytes
- CD163 macrophages
The outcome will be assesed depending on prostate biopsy results.
Timepoint [1] 304009 0
Six months after intervention

Eligibility
Key inclusion criteria
Patients with proven inflammation in prostatic biopsy
Minimum age
40 Years
Maximum age
85 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have been already treated for LUTS with herbal medication.
Patients who have been diagnosed with prostate cancer at the first biopsy.
Patients who underwent pelvic radiotherapy for any reason.
Patients with a permanent urethral catheter.
Patient with a previous TURP or intravesical instillations due to bladder cancer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
www.randomizer.org, central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
We estimated, using current data, that a significant difference in inflammation score could be standarized at 25%. Power of the study was calculated at 90%, using https://www.dssresearch.com power calculator, so each Group should have 50 enrollments (totally 100).
Statistical analysis of our results will take place using non-parametrical methods.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2012
Actual
20/07/2012
Date of last participant enrolment
Anticipated
31/12/2014
Actual
22/12/2014
Date of last data collection
Anticipated
Actual
13/07/2015
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 5258 0
Greece
State/province [1] 5258 0
Thessaly

Funding & Sponsors
Funding source category [1] 298557 0
Other
Name [1] 298557 0
Prof. Gravas Stavros
Country [1] 298557 0
Greece
Funding source category [2] 298558 0
Other
Name [2] 298558 0
None
Country [2] 298558 0
Greece
Primary sponsor type
Individual
Name
Prof. Stavros Gravas
Address
Prof. Stavros Gravas
6-8 Fediou Str
41221
Larissa
Country
Greece
Secondary sponsor category [1] 286448 0
None
Name [1] 286448 0
Address [1] 286448 0
Country [1] 286448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289673 0
Scientific Committee University Hospital of Larisa
Ethics committee address [1] 289673 0
Ethics committee country [1] 289673 0
Greece
Date submitted for ethics approval [1] 289673 0
Approval date [1] 289673 0
08/06/2011
Ethics approval number [1] 289673 0

Summary
Brief summary
The aim of the study is to determine the effect of Serenoa Repens use on prostatic inflammation, based on histological and immunohistochemical criteria. Patients with prostatic inflammation based on biopsy results are randomized to receive either Serenoa Repens 320mg/d (Group 1) or no treatment (Group 2). Patients will receive a second biopsy 6 months later. Inflammation score and immunohistochemical results, with or without treatment with Serenoa Repens, will be statistically compared, so as to evaluate the effect on the prostatic inflammation.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 41894 0
Prof Gravas Stavros, Urology Profesor, Urology Department of University of Thessaly
Address 41894 0
Feidiou 6-8 Str
41221
Larissa
Country 41894 0
Greece
Phone 41894 0
+306944626086
Fax 41894 0
Email 41894 0
[email protected]
Contact person for public queries
Name 41895 0
Dr Samarinas Michael Urology Resident, Urology Department of University of Thessaly
Address 41895 0
Urology Resident, Urology Department of University of Thessaly
Viopolis Mezourlo
41335
Larisa
Country 41895 0
Greece
Phone 41895 0
+306946006798
Fax 41895 0
Email 41895 0
[email protected]
Contact person for scientific queries
Name 41896 0
Prof Gravas Stavros Urology Professor, Urology Department of University of Thessaly
Address 41896 0
Feidiou 6-8 Str
41221
Larissa
Country 41896 0
Greece
Phone 41896 0
+306944626086
Fax 41896 0
Email 41896 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe clinical impact of hexanic extract of Serenoa repens in men with prostatic inflammation: A post Hoc analysis of a randomized biopsy study.2020https://dx.doi.org/10.3390/jcm9040957
N.B. These documents automatically identified may not have been verified by the study sponsor.