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General information
IRCT20200825048515N54
IRCT20200825048515N59
IRCT20200825048515N54IRCT20200825048515N59
2022-06-13, 1401/03/23
2022-09-12, 1401/06/21
2022-0609-13 0512 17:0538:0332
2022-07-21, 1401/04/30
2022-09-21, 1401/06/30
2022-0709-21 00:00:00
2022-09-22, 1401/06/31
2023-03-21, 1402/01/01
20222023-0903-2221 00:00:00
Protocol summary
Study aim
Determining the effect of injectable dexamethasone administration on the frequency and excretion time of distal ureteral stones
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 100 patients
Settings and conduct
In this randomized double-blind clinical trial study, 100 eligible patients referred to Al-Zahra Hospital in Isfahan will be included in the study and randomly divided into two groups. Patients in the first group will be prescribed dexamethasone and in the control group distilled water. Then the frequency and time of stone excretion will be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include definitive diagnosis of distal ureteral stone less than 1 cm, age over 18 years, drug indication, and consent to participate in the study.
Exclusion criteria include benign prostatic hyperplasia (BPH), concomitant stenosis, contraindications to corticosteroids, and hydronephrosis.
Intervention groups
Intervention group 1: Patients in this group are treated orally with tamsulosin 0.4 mg/day for two weeks. In addition, an intramuscular injection of 8 mg dexamethasone will be given.
Control group: Patients in this group receive oral tamsulosin 0.4 mg/day for two weeks. In addition, 8 mg of distilled water will be injected intramuscularly within a week.
Main outcome variables
Frequent distal ureteral stone excretion, Time to excrete distal ureteral stones
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N59
Registration date:2022-09-12, 1401/06/21
Registration timing:prospective
Last update:2022-09-12, 1401/06/21
Update count:1
Registration date
2022-09-12, 1401/06/21
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-21, 1401/06/30
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of injectable dexamethasone on the frequency and excretion time of distal ureteral stones
Public title
Evaluation of the effect of injectable dexamethasone on excretion of distal ureteral stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of distal ureteral stones below 1 cm
Age over 18 years
Indicated for drug therapy
Satisfaction to participate in the study
Exclusion criteria:
Having benign prostatic hyperplasia (BPH) at the same time
Having a narrowing of the urethra
Contraindications to the use of corticosteroids
Existence of hydronephrosis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
En In this study, 100 eligible patients are randomly selected. For this, the letter A is written on 50 sheets, the letter B is written on 50 sheets, and each is placed in an envelope. Each patient is then asked to choose one of the envelopes. The patient is assigned to one of two groups depending on the selected envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two drugs, dexamethasone, and distilled water, are pre-prepared in similar syringes of the same volume and placed in coded packages, and delivered daily to the researcher. The researcher prescribes each drug without knowing the type. Also, the person recording the patient and clinical information and the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave, Azadi Square.
City
Isfaha
Province
Isfehan
Postal code
8174673461
Approval date
2021-04-10, 1400/01/21
Ethics committee reference number
IR.MUI.MED.REC.1400.015
Health conditions studied
1
Description of health condition studied
Calculus of ureter
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
Frequent distal ureteral stone excretion
Timepoint
Until the end of two weeks of intervention
Method of measurement
Observational
2
Description
Time to excrete distal ureteral stone
Timepoint
Until the end of two weeks of intervention
Method of measurement
Observational
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group are treated orally with Tamsulosin 0.4 mg / day for two weeks. In addition, an intramuscular injection of 8 mg dexamethasone will be given.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive oral tamsulosin 0.4 mg / day for two weeks. In addition, 8 mg of distilled water will be injected intramuscularly within a week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Reza Kazemi
Street address
Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dr.rezakazemi6788@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reza Kazemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Department, Al-Zahra Hospital, Hezar Jerib Street.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dr.rezakazemi6788@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Kazemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Department, Al-Zahra Hospital, Hezar Jerib Street.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dr.rezakazemi6788@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Shahrashoob
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Department, Al-Zahra Hospital, Hezar Jerib Street.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Shahram9229@gmail.com
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