Effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia: a single-blind randomized controlled trial
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Protocol summary
To assess the effect of tamsulosin with and without pumpkin seed oil on clinical symptoms in patients with benign prostatic hypertrophy
To assess the effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia
To assess the effect of tamsulosin with and withoutversus pumpkin seed oil on clinical symptoms in patients with benign prostatic hypertrophyhyperplasia
تعيين اثر تامسولوسین با و بدون روغن تخم کدو بر علایم بالینی در بیماران مبتلا به بزرگی خوش خیم پروستات
تعيين اثر تامسولوسین نسبت به روغن تخم کدو بر علایم بالینی در بیماران مبتلا به بزرگی خوش خیم پروستات
تعيين اثر تامسولوسین با و بدوننسبت به روغن تخم کدو بر علایم بالینی در بیماران مبتلا به بزرگی خوش خیم پروستات
Intervention group:
Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night plus capsule including pumpkin seed oil 360 mg (manufactured by Tehran Daru Pharmaceutical Co.) once every night for 3 months
Control group:
Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
Intervention group:
Pumpkin seed oil 360 mg (manufactured by Tehran Daru Pharmaceutical Co.) once every night for 3 months
Control group:
Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
Intervention group: Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night plus capsule including pumpkinPumpkin seed oil 360 mg (manufactured by Tehran Daru Pharmaceutical Co.) once every night for 3 months Control group: Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
گروه مداخله:
کپسول تامسولوسین 0.4 میلیگرم (ساخت شرکت داروسازی تسنیم) شبی یک عدد بعلاوه کپسول حاوی 360 میلیگرم روغن تخم کدوی (ساخت شرکت داروسازی تهران دارو) شبی یک عدد به مدت 3 ماه
گروه کنترل:
کپسول تامسولوسین 0.4 میلیگرم شبی یک عدد به مدت 3 ماه
گروه مداخله:
کپسول حاوی 360 میلیگرم روغن تخم کدوی (ساخت شرکت داروسازی تهران دارو) شبی یک عدد به مدت 3 ماه
گروه کنترل:
کپسول تامسولوسین 0.4 میلیگرم شبی یک عدد به مدت 3 ماه
گروه مداخله: کپسول تامسولوسین 0.4 میلیگرم (ساخت شرکت داروسازی تسنیم) شبی یک عدد بعلاوه کپسول حاوی 360 میلیگرم روغن تخم کدوی (ساخت شرکت داروسازی تهران دارو) شبی یک عدد به مدت 3 ماه گروه کنترل: کپسول تامسولوسین 0.4 میلیگرم شبی یک عدد به مدت 3 ماه
General information
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There has been a slight change in the intervention group that needs to be updated.
There has been a slight change in the intervention group that needs to be updated.
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در گروه نوع مداخله تغییر اندکی صورت گرفته است که لازم است پروپوزال به روز رسانی شود.
در گروه نوع مداخله تغییر اندکی صورت گرفته است که لازم است پروپوزال به روز رسانی شود.
Effect of tamsulosin with and without pumpkin seed oil on clinical symptoms in patients with benign prostatic hypertrophy
Effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia
Effect of tamsulosin with and withoutversus pumpkin seed oil on clinical symptoms in patients with benign prostatic hypertrophyhyperplasia
تأثیر تامسولوسین با و بدون روغن تخم کدو بر علایم بالینی در بیماران مبتلا به بزرگی خوش خیم پروستات
تأثیر تامسولوسین نسبت به روغن تخم کدو بر علایم بالینی در بیماران مبتلا به بزرگی خوش خیم پروستات
تأثیر تامسولوسین با و بدوننسبت به روغن تخم کدو بر علایم بالینی در بیماران مبتلا به بزرگی خوش خیم پروستات
Effect of tamsulosin with and without pumpkin seed oil on clinical symptoms in patients with benign prostatic hypertrophy: a single-blind randomized controlled trial
Effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia: a single-blind randomized controlled trial
Effect of tamsulosin with and withoutversus pumpkin seed oil on clinical symptoms in patients with benign prostatic hypertrophyhyperplasia: a single-blind randomized controlled trial
تأثیر تامسولوسین با و بدون روغن تخم کدو بر علایم بالینی در بیماران مبتلا به بزرگی خوش خیم پروستات: کارآزمایی بالینی تصادفی شده یک سو کور
تأثیر تامسولوسین نسبت به روغن تخم کدو بر علایم بالینی در بیماران مبتلا به بزرگی خوش خیم پروستات: کارآزمایی بالینی تصادفی شده یک سو کور
تأثیر تامسولوسین با و بدوننسبت به روغن تخم کدو بر علایم بالینی در بیماران مبتلا به بزرگی خوش خیم پروستات: کارآزمایی بالینی تصادفی شده یک سو کور
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.
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 "tamsulosin group" on one sheet and "pumpkin group" 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.
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 "interventiontamsulosin group" on one sheet and "controlpumpkin group" 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.
تخصیص تصادفی بیماران به گروههای مداخله و کنترل به صورت قرعه کشی. برای این منظور دو برگه تهیه می کنیم روی یکی "مداخله" و روی دیگری "کنترل" می نویسیم. سپس با مراجعه هر بیمار، یکی از برگه ها به صورت تصادفی برداشته و بیمار را به گروه مداخله یا کنترل اختصاص می دهیم.
تخصیص تصادفی بیماران به گروههای مداخله و کنترل به صورت قرعه کشی. برای این منظور دو برگه تهیه می کنیم روی یکی "تامسولوسین" و روی دیگری "تخم کدو" می نویسیم. سپس با مراجعه هر بیمار، یکی از برگه ها به صورت تصادفی برداشته و بیمار را به گروه مداخله یا کنترل اختصاص می دهیم.
تخصیص تصادفی بیماران به گروههای مداخله و کنترل به صورت قرعه کشی. برای این منظور دو برگه تهیه می کنیم روی یکی "مداخلهتامسولوسین" و روی دیگری "کنترلتخم کدو" می نویسیم. سپس با مراجعه هر بیمار، یکی از برگه ها به صورت تصادفی برداشته و بیمار را به گروه مداخله یا کنترل اختصاص می دهیم.
Intervention groups
#1
Intervention group: Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night plus capsule including pumpkin seed oil 360 mg (manufactured by Tehran Daru Pharmaceutical Co.) once every night for 3 months
Control group: Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
InterventionControl group: Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night plus capsule including pumpkin seed oil 360 mg (manufactured by Tehran Daru Pharmaceutical Co.) once every night for 3 months
گروه مداخله: کپسول تامسولوسین 0.4 میلیگرم (ساخت شرکت داروسازی تسنیم) شبی یک عدد بعلاوه کپسول حاوی 360 میلیگرم روغن تخم کدوی (ساخت شرکت داروسازی تهران دارو) شبی یک عدد به مدت 3 ماه
گروه مداخله: کپسول حاوی 360 میلیگرم روغن تخم کدوی (ساخت شرکت داروسازی تهران دارو) شبی یک عدد به مدت 3 ماه
گروه مداخله: کپسول تامسولوسین 0.4 میلیگرم (ساخت شرکت داروسازی تسنیم) شبی یک عدد بعلاوه کپسول حاوی 360 میلیگرم روغن تخم کدوی (ساخت شرکت داروسازی تهران دارو) شبی یک عدد به مدت 3 ماه
Protocol summary
Study aim
To assess the effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia
Design
This is a single-blind randomized clinical trial, phase II, in which 80 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with benign prostatic hypertrophy 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. This trial will be single-blinded so that the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 50 to 90 years,
Benign prostatic hypertrophy
Exclusion criteria:
Indication of surgery,
Taking medications for the treatment of benign prostatic hypertrophy in the past 6 months
Intervention groups
Intervention group:
Pumpkin seed oil 360 mg (manufactured by Tehran Daru Pharmaceutical Co.) once every night for 3 months
Control group:
Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
There has been a slight change in the intervention group that needs to be updated.
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N340
Registration date:2020-02-19, 1398/11/30
Registration timing:retrospective
Last update:2021-07-25, 1400/05/03
Update count:1
Registration date
2020-02-19, 1398/11/30
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
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia: a single-blind randomized controlled trial
Public title
Effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 50 to 90 years,
Benign prostatic hypertrophy
Exclusion criteria:
Indication of surgery,
Taking medications for treatment of benign prostatic hypertrophy in the past 6 months
Age
From 50 years old to 90 years old
Gender
Male
Phase
2
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
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 "tamsulosin group" on one sheet and "pumpkin group" 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)
Single blinded
Blinding description
The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as single-blind.
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
2019-08-10, 1398/05/19
Ethics committee reference number
IR.UMSHA.REC.1398.429
Health conditions studied
1
Description of health condition studied
Benign prostatic hypertrophy
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate
Primary outcomes
1
Description
Clinical symptoms
Timepoint
Before the intervention and then monthly for 3 months
Method of measurement
By taking history
2
Description
Measuring prostate
Timepoint
Before the intervention and 3 months later
Method of measurement
By sonography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
Category
Treatment - Drugs
2
Description
Control group: Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan city
Full name of responsible person
Dr Nikan Zerafatjoo
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
nikan_z@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
Dr Nikan Zerafatjoo
Position
Resident of Urology
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
nikan_z@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
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
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