To determine oral administration of Peganum in nocturia in patients with benign prostatic hyperplasia, single- center, phase 3 trial, Single-blind 2) Participant: Inclusion criteria: Inclusion criteria: patients with benign prostatic enlargement.
Exclusion criteria: patients undergoing surgery; a significant anomaly functional or anatomical urinary tract; thyroid dysfunction; prostate cancer; patients with mental disorders 3) Population: 70 patients divide in case and control 4 ) Interventions : intervention group will be used of harmala seeds1 gr orally twice daily and the control group did not receive any treatment 5) Comparison: one months 6) Outcome: reduction of nocturia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091419151N1
Registration date:2014-09-19, 1393/06/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-19, 1393/06/28
Registrant information
Name
Majid Shirani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 0065
Email address
shirani.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Scientes
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral administration of Peganum in nocturia in patients with benign prostatic hyperplasia
Public title
Evaluation of oral administration of Peganum in nocturia in patients with benign prostatic hyperplasia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with benign prostatic enlargement.
Exclusion criteria: patients undergoing surgery; a significant anomaly functional or anatomical urinary tract; thyroid dysfunction; prostate cancer; patients with mental disorders
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord,Rahmatieh, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2013-09-08, 1392/06/17
Ethics committee reference number
4-5-92
Health conditions studied
1
Description of health condition studied
Hyperplasia of prostate
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
decrease of nocturia
Timepoint
1 months latter
Method of measurement
examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will be used of harmala seeds1 gr orally twice daily.
Category
Treatment - Drugs
2
Description
the control group did not receive any treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shahrekord urology clinic
Full name of responsible person
Shirani Majid
Street address
Shahrekord, Shahrekord University Of Medical Sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Scie
Full name of responsible person
Vice chancellor for research of Shahrekord University of Medical Scie
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
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 of Shahrekord University of Medical Scie
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
Shahrekord University of Medical Sciences
Full name of responsible person
Shirani Majid
Position
Urological Surgeons, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 0065
Fax
Email
keivaniz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Shirani Majid
Position
Urological Surgeons, Assistant Professor Sciences
Other areas of specialty/work
Street address
Shahrekord , Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 0065
Fax
Email
keivaniz2yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Shirani Majid
Position
Urological Surgeons, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1334 9507
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)