Determining the effect of isosorbide dinitrate on the duration of excretion of kidney stones after Extra Corporeal Shock Wake Lithotripsy
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial in 178 patients. Lottery was used for randomization.
Settings and conduct
176 patients with stones smaller than 20 mm in the pelvic area, referred to the Extracorporeal Shock Wake Lithotripsy department of Rafsanjan Moradi Hospital during 2024 will be examined. After stone breaking, the patients were randomly divided into two intervention groups (taking 20 mg isosorbide tablets every 12 hours for 2 weeks) and the control group (placebo, an ineffective substance in the form of a tablet that is similar in shape and taste to isosorbide tablets and one of the pharmacists will be prepared) will be placed for 2 weeks.
Participants/Inclusion and exclusion criteria
Weight under 100 kg, stone size up to 20 mm, no history of kidney failure, no history of stone breaking, no history of kidney surgery, no history of stone removal, no history of taking diuretic drugs, no history of taking smooth muscle relaxant drugs, and no history of moderate or severe hydronephrosis.
Intervention groups
The intervention group used 20 mg isosorbide tablets every 12 hours for 2 weeks
Main outcome variables
Stone free
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150317021497N9
Registration date:2023-12-20, 1402/09/29
Registration timing:prospective
Last update:2023-12-20, 1402/09/29
Update count:0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
Mohammadreza Mokhtaree
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34260081
Email address
mrmokhtaree@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of isosorbide dinitrate on the duration of kidney stone free after Extra Corporeal Shock Wake Lithotripsy
Public title
The effect of isosorbide on the duration of Renal stone free
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
weight under 100 kg
stone size up to 20 mm
Exclusion criteria:
Moderate and severe hydronephrosis
History of taking smooth muscle relaxant drugs
History of taking smooth muscle relaxant drugs
History of stone removal
History of kidney surgery
history of Extra Corporeal Shock Wake Lithotripsy
History of renal failure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Randomized
Randomization description
Random method and after maximum effort for matching based on age, sex, weight and size of the stone
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst did not know about the grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd.-Central Organization-Building No. 3, Research and Technology Vice-Chancellor
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2019-02-02, 1397/11/13
Ethics committee reference number
IR.RUMS.REC.1397.200
Health conditions studied
1
Description of health condition studied
Calculus of kidney
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Duration of stone free
Timepoint
After prescribing the drug
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administration of isosorbide
Category
Treatment - Drugs
2
Description
Control group: Placebo administration
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Moradi Hospital, Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Nazari
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
drnazari57@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Imam Ali Blvd.-Central Organization-Building No. 3, Research and Technology Vice-Chancellor
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0086
Email
vcrt@rums.ac.ir
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
Reza Vazirinejad
Position
Vice Chancellery for Research & Technology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Imam Ali Blvd.-Central Organization-Building No. 3, Research and Technology Vice-Chancellor
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0086
Email
vcrt@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Nazari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Email
drnazari57@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Mokhtaree
Position
Master's Degree
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Education Department, Moradi Hospital, Shohada Street
City
Rafsanjan
Province
Kerman
Postal code
7713951151
Phone
+98 34 3426 0080
Fax
Email
mrmokhtaree@rums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
To receive the data, a valid letter from the highest authority of the person's university is required. Any analysis on the data will be done with the knowledge and permission of the researchers.
From where data/document is obtainable
Vice Chancellery for Research & Technology of Rafsanjan University of Medical Sciences
What processes are involved for a request to access data/document
After submitting the request to the Research and Technology Vice-Chancellor of Rafsanjan University of Medical Sciences, the review process will begin. After reviewing the application and approval, the data will be provided to the applicant.