Effect of new combined medication “Young Prostate" versus standard treatment on clinical symptoms in patients with benign prostate hypertrophy and overactive bladder: a randomized clinical trial
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Protocol summary
Intervention group:
New combined capsule “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months.
Control group:
Tablets Finasteride 5 mg and Trazosin 2 mg and oxytocin 5 mg daily for 6 months.
Intervention group:
New combined tablet “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months.
Control group:
Tablets Finasteride 5 mg and Trazosin 2 mg and oxytocin 5 mg daily for 6 months.
Intervention group: New combined capsuletablet “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months. Control group: Tablets Finasteride 5 mg and Trazosin 2 mg and oxytocin 5 mg daily for 6 months.
گروه مداخله:
کپسول ترکیبی جدید Young prostate (حاوی ترازوسین 2 میلی گرم و فیناستراید 5 میلی گرم و اکسی بوتینین 5 میلی گرم) روزانه به مدت 6 ماه.
گروه کنترل:
قرص فیناستراید 5 میلی گرم روزانه و ترازوسین 2 میلی گرم روزانه و اکسی بوتینین 5 میلی گرم روزانه به مدت 6 ماه.
گروه مداخله:
قرص ترکیبی جدید Young prostate (حاوی ترازوسین 2 میلی گرم و فیناستراید 5 میلی گرم و اکسی بوتینین 5 میلی گرم) روزانه به مدت 6 ماه.
گروه کنترل:
قرص فیناستراید 5 میلی گرم روزانه و ترازوسین 2 میلی گرم روزانه و اکسی بوتینین 5 میلی گرم روزانه به مدت 6 ماه.
گروه مداخله: کپسولقرص ترکیبی جدید Young prostate (حاوی ترازوسین 2 میلی گرم و فیناستراید 5 میلی گرم و اکسی بوتینین 5 میلی گرم) روزانه به مدت 6 ماه. گروه کنترل: قرص فیناستراید 5 میلی گرم روزانه و ترازوسین 2 میلی گرم روزانه و اکسی بوتینین 5 میلی گرم روزانه به مدت 6 ماه.
General information
empty
The form of the medication was changed from capsule to tablet due to the ease of manufacture.
The form of the medication was changed from capsule to tablet due to the ease of manufacture.
empty
شکل دارو به دلیل سهولت ساخت از حالت کپسول به قرص تغییر داده شد.
شکل دارو به دلیل سهولت ساخت از حالت کپسول به قرص تغییر داده شد.
Intervention groups
#1
Intervention group: New combined capsule “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months
Intervention group: New combined tablet “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months
Intervention group: New combined capsuletablet “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months
گروه مداخله: کپسول ترکیبی جدید Young prostate (حاوی ترازوسین 2 میلی گرم و فیناستراید 5 میلی گرم و اکسی بوتینین 5 میلی گرم) روزانه به مدت 6 ماه
گروه مداخله: قرص ترکیبی جدید Young prostate (حاوی ترازوسین 2 میلی گرم و فیناستراید 5 میلی گرم و اکسی بوتینین 5 میلی گرم) روزانه به مدت 6 ماه
گروه مداخله: کپسولقرص ترکیبی جدید Young prostate (حاوی ترازوسین 2 میلی گرم و فیناستراید 5 میلی گرم و اکسی بوتینین 5 میلی گرم) روزانه به مدت 6 ماه
Protocol summary
Study aim
To assess the effect of new combined medication “Young Prostate" versus standard treatment on clinical symptoms in patients with benign prostate hypertrophy and overactive bladder
Design
This is a randomized clinical trial, in which 64 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with benign prostate hypertrophy and overactive bladder referring to the Shahid Beheshti Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 40 to 65 years,
Benign prostate hypertrophy,
Overactive bladder,
Exclusion criteria:
History of prostate surgery
Intervention groups
Intervention group:
New combined tablet “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months.
Control group:
Tablets Finasteride 5 mg and Trazosin 2 mg and oxytocin 5 mg daily for 6 months.
Main outcome variables
Sexual desire, prostate size
General information
Reason for update
The form of the medication was changed from capsule to tablet due to the ease of manufacture.
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N386
Registration date:2021-03-07, 1399/12/17
Registration timing:prospective
Last update:2021-03-16, 1399/12/26
Update count:1
Registration date
2021-03-07, 1399/12/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of new combined medication “Young Prostate" versus standard treatment on clinical symptoms in patients with benign prostate hypertrophy and overactive bladder: a randomized clinical trial
Public title
Effect of new combined medication “Young Prostate" on clinical symptoms in patients with benign prostate hypertrophy and overactive bladder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 40 to 65 years
Benign prostate hypertrophy
Overactive bladder
Exclusion criteria:
History of prostate surgery
Age
From 18 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-01-19, 1399/10/30
Ethics committee reference number
IR.UMSHA.REC.1399.872
Health conditions studied
1
Description of health condition studied
Benign prostate hypertrophy
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate
Primary outcomes
1
Description
Sexual desire
Timepoint
Before the intervention and 3 and 6 months after that
Method of measurement
By taking history
2
Description
Prostate size
Timepoint
Before the intervention and 3 and 6 months after that
Method of measurement
Using ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: New combined tablet “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months
Category
Treatment - Drugs
2
Description
Control group: Tablets Finasteride 5 mg and Trazosin 2 mg and oxytocin 5 mg daily for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan city
Full name of responsible person
Mohammad Hamedanian
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
mohammad_hamedanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Hamedanian
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mohammad_hamedanian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Amirzargar
Position
Urologist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr_amirzargar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available