The purpose of study was assessment of efficacy of stinging nettle medicine in reducing clinical symptoms patients with benign prostatic hyperplasia. This study was conducted as a randomized double-blind, placebo control, single center and phase II trial. 100 patients with benign prostatic hyperplasia, between 40 and 80 years old that do not have any urinary and kidney diseases were selected from hospitalized benign prostatic hyperplasia patients in urology ward. Placebo and main drug was utilized by patients in 8 weeks during 1 May to 1 July 2011. After entering the study, using a prostate symptom severity measuring scale was determined the severity of patient’s symptoms in 9 times (before the start of the study and at the end of each week).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107295069N4
Registration date:2011-08-03, 1390/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-03, 1390/05/12
Registrant information
Name
Alireza Ghorbani Birgani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 61 1229 8173
Email address
ghorbani@iaug.ac.ir
Recruitment status
Recruitment complete
Funding source
Gachsaran Islamic Azad University
Expected recruitment start date
2011-05-01, 1390/02/11
Expected recruitment end date
2011-07-01, 1390/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Stinging Nettle (Urtica Dioica) in Patients with Benign Prostatic Hyperplasia
Public title
The Efficacy of Stinging Nettle (Urtica Dioica) in Patients with Benign Prostatic Hyperplasia: A Randomized Double-Blind Study in 100 Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: known case of Benign Prostatic Hyperplasia, between 40 and 80 years old. Exclusion criteria: the presence of urinary and kidney diseases.
Age
From 40 years old to 80 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Postal code
32356
Approval date
2011-04-19, 1390/01/30
Ethics committee reference number
335
Health conditions studied
1
Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
N 40.0
ICD-10 code description
بزرگی خوش خیم غده پروستات
Primary outcomes
1
Description
Stinging Nettle Medicine
Timepoint
before intervention and every week for eight weeks
Method of measurement
Prostate Symptom Severity Measuring Scale
Secondary outcomes
empty
Intervention groups
1
Description
Stinging Nettle, 300 mg capsule twice a day for 8 weeks in intervention group
Category
Treatment - Drugs
2
Description
Placebo, 300 mg capsule twice a day for 8 weeks in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Imam Khomeinie Hospital
Full name of responsible person
Alireza Ghorbani Birgani
Street address
Azadegan Ave-Imam Khomeinie
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gachsaran Islamic Azad University
Full name of responsible person
Saman Moosavian
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gachsaran Islamic Azad University
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
Gachsaran Islamic Azad University
Full name of responsible person
Saman Moosavian
Position
Faculty Member/Master
Other areas of specialty/work
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Postal code
32356
Phone
+98 74 2333 4607
Fax
+98 74 2333 4751
Email
info@iaug.ac.ir
Web page address
www.iaug.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gachsaran Islamic Azad University
Full name of responsible person
Alireza Ghorbani Birgani
Position
Faculty Member/Master
Other areas of specialty/work
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Postal code
75817
Phone
+98 74 2333 4600
Fax
+98 27 02090
Email
alenc5@gmail.com
Web page address
www.iaug.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gachsaran Islamic Azad University
Full name of responsible person
Saman Moosavian
Position
Faculty Member/Master
Other areas of specialty/work
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Postal code
32356
Phone
+98 74 2333 4607
Fax
+98 74 2333 4751
Email
info@iaug.ac.ir
Web page address
www.iaug.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)