The aim of this study is investigating the effect of a chosen drug of Persian medicine on dysuria during radiotherapy for localized prostate cancer. The statistical sample of the study includes 60 patients suffering from prostatic Adenocarcinoma in Shohada Tahjrish Hospital of Shahid Beheshti University of Medical Sciences who are under treatment by Radiotherapy. They must be able to Express dysuria and must not have foley catheter and must sign informed written consent. patients are randomly divided into interfering group and control group; One Group of these patients receives chosen drug and the other one receives Placebo during radiotherapy (about two months). Any Drug sensitivity and positive urine culture indicative of infection are Exclude criteria. Patients are visited every two weeks and evaluated with a 5 degree scoring system adopted from International Prostate Symptom Score (I-PSS) and intensity of dysuria is measured by a scoring system between zero to ten (zero meaning no irritation and ten meaning no tolerable dysuria). At the end of two months, data will be recorded and analysed at the end of the research.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100711026N1
Registration date:2013-12-09, 1392/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-09, 1392/09/18
Registrant information
Name
Amir Mohammad Jaladat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6648 5805
Email address
drjaladat@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-10-27, 1392/08/05
Expected recruitment end date
2014-03-16, 1392/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of a chosen drug of Persian medicine on dysuria during radiotherapy for localized prostate cancer
Public title
Effect of a chosen drug of Persian medicine on dysuria during radiotherapy for localized prostate cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients who are planed radiotherapy with impression of prostate adenocarcinema and signed informed consent, those who are able to Express dysuria and do not have not have foley catheter.
exclusion criteria: Drug or placebo sensitivity and positive urine culture indicative of infection.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Research Institute for Islamic and Complementary Medicine (RICM)
Street address
Pyrnia Alley, Lalezarno Ave. Jomhoori Eslami St. Tehran, Iran
City
Tehran
Postal code
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
پ26/م ط/934
Health conditions studied
1
Description of health condition studied
prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Dysuria
Timepoint
Weekly during radiotherapy
Method of measurement
A modified IPSS (International Prostate Symptom Score)
Secondary outcomes
1
Description
Dysuria severity
Timepoint
Weekly during radiotherapy
Method of measurement
Visual Analog Scale 0-10
Intervention groups
1
Description
All patients in intervention group take powder of Malva sylvestris in 5mg packets twice a day orally with a glass of water.
Category
Prevention
2
Description
All patients in control group take powder of placebo which is designed for this study in 5mg packets twice a day orally with a glass of water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaie Tajrish Hospital
Full name of responsible person
Street address
Shohadaie Tajrish Hospital,Tajrish
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dariush Mahmoodi
Street address
Office of Vice Chancellor for Research, Third floor, Faculty of Traditional Medicine, Behesht St., Vahdat Eslami St. (South Hafiz), Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences, department-of-traditional-medicine
Full name of responsible person
Amir Mohammad Jaladat
Position
MD
Other areas of specialty/work
Street address
No. 59, Ghasrodasht, Shiraz
City
Shiraz
Postal code
7183894993
Phone
+98 71 1626 8875
Fax
Email
drjaladat@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences Faculty of Pharmacy
Full name of responsible person
Gholamreza Amin
Position
PhD
Other areas of specialty/work
Street address
Enghelab Street, Tehran University of Medical Sciences, School of Pharmacy
City
Tehran
Postal code
14155/6451
Phone
+98 21 6648 2609
Fax
Email
amin@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Iranian traditional medicine, Tehran University of Medical Sciences
Full name of responsible person
Amir Mohammad Jaladat
Position
MD
Other areas of specialty/work
Street address
Behesht Clinic, Behesht St., Vahdat-e Eslami st. (South Hafiz)
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
Email
drjaladat@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)