Comparing the effect of Montelukast in the treatment of clinical manifestations of pyelonephritis.
Design
This study is a clinical trial in Phase 4. children who have been diagnosed with pyelonephritis, based on urine test findings and DSMA scans, are selected as the study group. In this study, 100 children who have inclusion criteria are included. Patients are randomly and based on block approach assigned into two groups: 50 children in the intervention group and 50 children in the control group. During the treatment, the symptoms of urination are monitored continuously.
Settings and conduct
This study was carried out as a clinical trial at the Pediatric Clinic of Amir Kabir Hospital in Arak, Also the study will also be single blinded in which patients will be blinded in study.
Participants/Inclusion and exclusion criteria
Patients with pyelonephritis who have clinical symptoms associated with it, according to a certified physician, will be included in this study. Also, children or parents who are reluctant to continue study, will be excluded from our study.
Intervention groups
First group: In the first group, who are taking pyelonephritis usual treatment with montelukast, montelukast is prescribed at a dose of 5 mg / day. Second group: In the second group of patients taking only pyelonephritis usual treatment.
Main outcome variables
Symptoms of Pyelonephritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190303042893N1
Registration date:2019-03-17, 1397/12/26
Registration timing:registered_while_recruiting
Last update:2019-03-17, 1397/12/26
Update count:0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Tayebe Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3437 0143
Email address
nazaridrt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effect of Montelukast on the Symptoms of Pyelonephritis in Children.
Public title
The effect of Monteluca on the symptoms of pyelonephritis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pyelonephritis with clinical symptoms of pyelonephritis and satisfaction with the studyThey are selected as the study group.
Satisfaction to participate in the study
Exclusion criteria:
Children with underlying illness of kidney, liver and heart.
Age
From 3 years old to 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomization we will use the block method, Accordingly, the patients under study are divided into two groups.
The allocation of patients in two groups was based on demographic characteristics and their matching.
Based on this, after considering the patients' demographic data, patients were divided into two equal groups of patients, they enrolled in the study and performed desired intervention on them.
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in groups do not know the used drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences and Health Services Deputy of research and t
Street address
Student Research Committee, Arak University of Medical Sciences, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
IR.ARAKMU.REC.1397.304
Health conditions studied
1
Description of health condition studied
Pyelonephritis
ICD-10 code
N10
ICD-10 code description
Acute tubulo-interstitial nephritis
Primary outcomes
1
Description
Symptoms of Pyelonephritis
Timepoint
Before taking the drug and 14 days after taking medication
Method of measurement
Registration of symptoms in the checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, Montelukast is prescribed at a dose of 5 mg/day.
Category
Treatment - Drugs
2
Description
Control group: In the first group, only the usual treatments of pyelonephritis is used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Tayebe nazari
Street address
Student Research Committee, Arak University of Medical Sciences, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3526
Email
paramed@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3526
Fax
+98 86 3417 3526
Email
paramed@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hasan Taher Ahmadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Clinical Research Development Center of Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3313 5075
Email
HasanTaherAhmadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parsa Yousefi Chayjan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Clinical Research Development Center of Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3526
Email
ParsaYousefi23@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Manije kahbazi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Clinical Research Development Center of Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3526
Email
Kahbazi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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