Efficacy of hydrochlorothiazide at stone free time after extra corporeal shock wake lithotripsy on patients referred to ESWL ward of Moradi hospital of Rafsanjan
Study of the Effect of Hydrochlorothiazide on the Duration of Stone free after Extra corporal shock wave litotripsy
Design
In this research, 276 eligible patients with Upper ureter stone referring to Moradi hospital were chosen purposefully. Then, patients were randomly divided into two control and intervention groups and a code was allocated to each one of them.
Settings and conduct
Patients in the intervention group, after ESWL, receive 25 mg of hydrochlorothiazide tablets every 12 hours for two weeks. The control group received vitamin B1 tablets every 12 hours for two weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Upper ureter stones under 20 mm
Exclusion criteria: Renal diseases, history of surgery, No Informed consent
Intervention groups
Patients in the intervention group, after ESWL, receive 25 mg of hydrochlorothiazide tablets twice a day for two weeks. The control group received vitamin B1 tablets for two weeks.
Main outcome variables
Stone free duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171104037212N2
Registration date:2018-01-24, 1396/11/04
Registration timing:registered_while_recruiting
Last update:2018-01-24, 1396/11/04
Update count:0
Registration date
2018-01-24, 1396/11/04
Registrant information
Name
Alireza Nazari
Name of organization / entity
Rafsanjan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3426 0080
Email address
dr.nazari@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of medical sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of hydrochlorothiazide at stone free time after extra corporeal shock wake lithotripsy on patients referred to ESWL ward of Moradi hospital of Rafsanjan
Public title
Efficacy of hydrochlorothiazide at renal pelvis stone free time after extra corporeal shock wake lithotripsy (ESWL)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Renal pelvic stone
Stone size equal or below 20 millimeters
Exclusion criteria:
Renal failure
History of ٍExtar corporeal shock wave lithotripsy
History of renal surgery
History of stone passage
History of using Diuretic drugs
History of using smooth muscle relaxant drugs
Patients with moderate or severe hydronephrosis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
278
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, radiologist, nurse do not know how to grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in medical researchs
Street address
Shohada
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
IR.RUMS.REC.1394.176
Health conditions studied
1
Description of health condition studied
Stone in kidney
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
The duration, the number of days from the time of the Extracorporeal shock wave lithotripsy to the time of last stone fragment passage
Timepoint
Day after Extracorporeal shock wave lithotripsy
Method of measurement
Check list
Secondary outcomes
1
Description
Stone free
Timepoint
daily
Method of measurement
Check list
Intervention groups
1
Description
Intervention group: Hydrochlorothiazide Tablet administration 25 mg, every 12 hours for two weeks
Category
Treatment - Drugs
2
Description
Control group: Tablet Vitamin B1 administration 150mg, every 12 hours for two weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Moradi hospital
Full name of responsible person
Alireza Nazari
Street address
Shohada
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
dr.nazari@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh, PhD
Street address
Imam Ali, Blvd
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3428 0038
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of medical sciences
Full name of responsible person
Mohammadreza Mokhtaree
Position
education expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Education unit, Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Fax
Email
mrmokhtaree@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of medical scieces
Full name of responsible person
Alireza Nazari
Position
Urology specialist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Moradi hospital, Shohada Street
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Fax
Email
dr.nazari@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Mokhtaree
Position
clinical education staff
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shohada
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 983434260080
Fax
Email
mrmokhtaree@rums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Non-approval of the Ethics Committee
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
Yes - There is 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
Title and more details about the data/document
Checklists are available
When the data will become available and for how long
2018
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Academic member
From where data/document is obtainable
mrmokhtaree@yahoo.com
What processes are involved for a request to access data/document
Agreement of the researchers, agreement of the authorities of the organization