Effect of combination therapy of coenzyme Q10 and L carnitine and finasteride on treatment management in patients with lower urinary tract symptoms ( LUTS) due to benign prismatic hyperplasia (BPH)
Determining the effectiveness of combination therapy of coenzyme Q10 and L carnitine and finasteride on treatment management in patients with lower urinary tract symptoms due to benign prismatic hyperplasia
Design
Clinical trial with control group, randomization, double blind,3 phase in to 50 patients ,four blocks are used to randomization
Settings and conduct
In faghihi hospital،double blind clinical trial, at the patient and evalutor level the outcome is blind, everyone consumes finasteride, we give the coenzyme Q10 and L carnitine in to intervention group and placebo in to control group
Participants/Inclusion and exclusion criteria
Prostate volume :40-60cc
IPSS(International prostate symptom score):40-60cc
50-75 years old
Intervention groups
Intervention gruop: finasteraid, L carnitine, coenzyme Q10
Control group : finasteraid, placebo
Main outcome variables
prostate volume, IPSS(International prostate symptom score),IIEF(International index of erectile function), PSA(prostate specific antigen), Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047893N1
Registration date:2020-07-26, 1399/05/05
Registration timing:registered_while_recruiting
Last update:2020-07-26, 1399/05/05
Update count:0
Registration date
2020-07-26, 1399/05/05
Registrant information
Name
Mahsa Norouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3822 9875
Email address
mahsanorouzi89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-25, 1399/04/05
Expected recruitment end date
2020-08-26, 1399/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combination therapy of coenzyme Q10 and L carnitine and finasteride on treatment management in patients with lower urinary tract symptoms ( LUTS) due to benign prismatic hyperplasia (BPH)
Public title
"coenzyme Q10 and L carnitine in Benign prismatic hyperplasia"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
50-75 years old
IPSS=8-19
Prostate volume 40-60 cc
Exclusion criteria:
urinary tract infections
severe liver disease
diabetes
recent treatment with 5 alpha reductase
recent treatment with phototherapy
treatment with antiandrogens and antidepressants
neurological bladder
bladder cancer
prostate cancer
Take atorvastatin
blood pressure
Age
From 50 years old to 75 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by the method of 4 blocks. The study is based on random allocation and is done by block balanced randomization method. Preparing a list of blocks and assigning numbers to them, selecting random numbers between 1 and 6, specifying the treatment allocation list
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial. Thus, the study at the level of the patient and the evaluator of the outcome of the results became blind. The drug and placebo capsules were divided into four-block blocks before filling. Only the researcher could decipher the contents of each capsule based on the original stored form of the random results. The person in charge of delivering the medicine, the patient, the doctor, and the person in charge of evaluating the consequences were not aware of the coding.The results of the control and intervention group under the headings of groups A and B were delivered to the statistical analyst.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical sciences
Street address
No 18, niyayesh 5 Ave,tohidy rad Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IR.SUMS.REC.1397.002
Health conditions studied
1
Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Lower urinary tract symptoms
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in prostate volume
Timepoint
The beginning the study and the end of study
Method of measurement
Sonography
Secondary outcomes
1
Description
IIEF
Timepoint
The beginning and the end of study
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: finasteraid, coenzyme Q10 100 mg , L carnitine 1000mg ,1tablet daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: finasteraid, plasebo ,1tablet daily for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid faghihi Hospital
Full name of responsible person
Mahsa norouzi
Street address
No 18, niyayesh 5 Are, tohidy rad Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3822 9875
Email
mahsanorouzi89@gmail.com
2
Recruitment center
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yones ghasemi
Street address
Deputy Director and Technology,7th Standard,Zandani Street, Shiraz University of Medical Sciences Standard ,Shiraz Town
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
ghasemiy@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa norouzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 18 , niyayesh 5 Are, Tohidy tad Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3822 9875
Email
mahsanorouzi89@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa norouzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Student
Street address
No18, niyayesh Ave , tohidy rad Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3822 9875
Email
mahsanorouzi89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa norouzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 18, niyayesh Ave ,tohidy rad Blvd ,Shiraz Town
City
Shiraz
Province
Fars
Postal code
713451978
Phone
0098 71 38229875
Email
mahsanorouzi89@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data can be shared
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Employed researchers
Under which criteria data/document could be used
Employed researchers
From where data/document is obtainable
Mahsa norouzi ,mahsanorouzi89@gmail.com
What processes are involved for a request to access data/document