Assessing the Effect of Oral Monte Locasta Compared with Pharmacology in Asthma Attacks, In addition to the common treatment of asthma attacks as a two-course, an accident in children aged 1-14 years with asthma
Assess the Effect of Oral Monte Locust Compared with placebo on Asthma Attacks In addition to the common treatment for asthma attacks
Design
Clinical trial with control group, double-blind, randomized, phase three, on 80 patients. Statistical software was also used for randomization
Settings and conduct
The study looked at the effect of oral monte locust in the treatment of acute asthma attacks in addition to the common treatment of asthma in children aged 1-14 years. There were two groups A or B (treatment and control). In addition to the usual treatment for asthma attacks, montelukast chewable tablets were given. The initiation of asthma treatment and the administration of montelukast were assessed for the clinical symptoms of asthma and oxygen-free Saturation O2 in room air. Both placebo and medication were divided into groups A and B. And the Grft.bymar and enforcement executives and other medical staff in the study were blinding.
Participants/Inclusion and exclusion criteria
All children aged 1-14 who have been diagnosed with an asthma attack and who have not taken corticosteroids or monte locusts in the last ten days
Intervention groups
In this intervention, patients were divided into two groups of intervention and control. In addition to the common treatment of asthma in both groups, the drug intervention group was given to the control group and the therapeutic effect was investigated in both groups.
Main outcome variables
Evaluation of the effect of oral monte locust compared to placebo in the treatment of asthma attacks in reducing symptoms during the attack and reducing hospitalization days and reducing the need for hospitalization in the PICU and also examining this trend in people with a history of atopy and familial disease.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200412047048N1
Registration date:2020-06-15, 1399/03/26
Registration timing:retrospective
Last update:2020-06-15, 1399/03/26
Update count:0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Masoomeh Sobhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4405 0743
Email address
masoomeh.sbh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2019-04-30, 1398/02/10
Trial completion date
2019-05-26, 1398/03/05
Scientific title
Assessing the Effect of Oral Monte Locasta Compared with Pharmacology in Asthma Attacks, In addition to the common treatment of asthma attacks as a two-course, an accident in children aged 1-14 years with asthma
Public title
Evaluation of the effect of oral monte locust in the treatment of acute asthma in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 1-14 years who are confirmed based on history and examination for asthma attack
Exclusion criteria:
Those with a history of taking corticosteroids or montelukast for the past ten days
All patients who developed a diagnosis other than asthma, such as pneumonia or bronchiolitis
Age
From 1 year old to 14 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
Actual sample size reached:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and their families were explained the study before prescribing the drug, and those who agreed to work were kept blind. The main researcher and the presenter were kept blind until the end of the study and the results were determined. The medical staff (nurses and other physician colleagues) were kept blind to the study. The project manager and statistical officer reviewed the data until the results were blind.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Unit 2,No. 9,Fifth Alley,Ali Hosseini St.,Ferdows Shargh Blvd.,Sadeghieh,
City
Tehran
Province
Tehran
Postal code
1481957141
Approval date
2019-02-02, 1397/11/13
Ethics committee reference number
IR.TUMS.CHMC.REC.1397.098
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Asthma
Timepoint
At the beginning of the patient's visit, 1,4,8,24,48 hours after the intervention and one week after discharge from the hospital
Method of measurement
Patient scoreboard
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, which included children aged 1-14 years with a diagnosis of asthma attack, Monte Lukast 5 mg / 4.5 tablets for children under 1 year of age and one complete tablet for children over 5 years of age at the time of the attack and then up to 7 times daily. The day was used. The above medicine was prepared by Obaidi Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
The control group included children aged 1-14 diagnosed with an asthma attack who were randomly selected and received placebo, which was both the same color and the same size as Monte Lukast. Complete tablets for children over 5 years of age were used during the attack and then daily for up to 7 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahrami hospital
Full name of responsible person
Masoomeh Sobhani
Street address
Bahrami Children's Hospital., Shahid Kiai St. (Qasem Abad)., not far from Imam Hossein., Damavand St
City
Tehran
Province
Tehran
Postal code
1481957141
Phone
+98 21 4405 0743
Email
masoomeh.sbh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Reza Malekzadeh
Street address
No. 1, Corner of Poursina, Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 4208
Email
masoomeh.sbh@gmail.com
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
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
Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Sobhani
Position
Non-faculty physician
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Unit 2, No. 9, Fifth Alley., Ali Hosseini St., Ferdows Shargh Blvd
City
Tehran
Province
Tehran
Postal code
1481957141
Phone
+98 21 4405 0743
Email
masoomeh.sbh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Sobhani
Position
Non-faculty physician
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Unit 2, No. 9, Fifth Alley., Ali Hosseini St., Ferdows Shargh Blvd
City
Tehran
Province
Tehran
Postal code
1481957141
Phone
+98 21 4405 0743
Email
masoomeh.sbh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Sobhani
Position
Non-faculty physician
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Unit 2, No. 9, Fifth Alley., Ali Hosseini St., Ferdows Shargh Blvd
City
Tehran
Province
Tehran
Postal code
1481957141
Phone
+98 21 4405 0743
Email
masoomeh.sbh@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