Effect of pumpkin seed oil versus tamsulosin on relieving clinical symptom in patients with benign prostatic hypertrophy: a single blinded randomized controlled trial
Objectives: To assess the effect of pumpkin seed oil versus tamsulosin on relieving clinical symptom in patients with benign prostatic hypertrophy.
Design: .a single blind randomized clinical trial.
Setting and conduct: The eligible patients with benign prostatic hypertrophy who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Benign prostatic hypertrophy; age of 50 to 80 years.
Exclusion criteria: Indication of surgery; no response to medical treatment.
Intervention group: Pumpkin seed oil 20 drop twice a day for 3 months.
Control group: Tamsulosin casual 0.4 mg per day for 3 months
Primary outcome: (a) clinical symptoms before, and 1, 2, and 3 months after intervention through history taking; (b) maximum urine flow rate before and 3 months after intervention using uroflowmetry.
Secondary outcome: Quality of life before and 3 months after intervention using standard quality of life questionnaire.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: The observer how will examine the patients will not be aware of the intervention. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611019014N128
Registration date:2016-11-09, 1395/08/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-09, 1395/08/19
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
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pumpkin seed oil versus tamsulosin on relieving clinical symptom in patients with benign prostatic hypertrophy: a single blinded randomized controlled trial
Public title
Effect of pumpkin seed oil versus tamsulosin on relieving clinical symptom in patients with benign prostatic hypertrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Benign prostatic hypertrophy; age of 50 to 80 years.
Exclusion criteria: Indication of surgery; no response to medical treatment.
Age
From 50 years old to 80 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: The observer how will examine the patients will not be aware of the intervention. Therefore, the trial will be run as single blind.
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 the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.UMSHA.REC.1395.5
Health conditions studied
1
Description of health condition studied
benign prostatic hypertrophy
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
clinical symptoms
Timepoint
before, and 1, 2, and 3 months after intervention
Method of measurement
through history taking
2
Description
maximum urine flow rate
Timepoint
before and 3 months after intervention
Method of measurement
using uroflowmetry
Secondary outcomes
1
Description
Quality of life
Timepoint
before and 3 months after intervention
Method of measurement
using standard quality of life questionnaire
Intervention groups
1
Description
Intervention group: Pumpkin seed oil 20 drop twice a day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Tamsulosin casual 0.4 mg per day for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Mahmood Ebrahimi
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Mahmood Ebrahimi
Position
Resident of Urology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
drmebrahimi22@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Mohammad Ali amirzargar
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
dr.amirzargar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)