Evaluation of the sedative effect of thyme in cough in children with asthma
Design
In this intervention study, 60 children with asthma who have the criteria to enter the study, are divided into two groups of 30 patients by block randomization method. Individuals' parents are explained about treatment methods and their benefits and complications, and informed consent is obtained
Settings and conduct
In this study, 60 children with asthma aged 5 to 12 years who referred to the allergy clinic of Ardabil University of Medical Sciences were randomly divided into two groups (30 patients in each group). After obtaining written consent from the parents, general information and cough and fever, wheezing and other symptoms of respiratory infection will be collected. For one month, the dried thyme extract test group will be given a dose of 1 to 4 grams per kilogram per day in 3 divided doses along with routine medical treatment, and the control group will receive only routine medical treatment.
Participants/Inclusion and exclusion criteria
Having asthma, age between 5-12 years, Lack of chronic disability or illness. Exclusion criteria: Failure to complete the course of treatment
Intervention groups
Intervention group: Patients in the intervention group will be given dried thyme extract for 1 month at a dose of 1 to 4 grams per kilogram per day in 3 divided doses along with routine medical treatment. Control group: The control group will only receive routine medical treatment
Main outcome variables
cough
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200505047310N1
Registration date:2020-06-10, 1399/03/21
Registration timing:prospective
Last update:2020-06-10, 1399/03/21
Update count:2
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
Elnaz Eskandarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 2251
Email address
e.eskandarpour@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sedative effect of thyme on cough in children 5 to 12 years of age with asthma
Public title
Evaluation of the sedative effect of thyme in cough in children with asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having asthma
age between 5-12 years
Lack of chronic disability or illness
Exclusion criteria:
Failure to complete the course of treatment
Age
From 5 years old to 12 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to one of two identified groups through blockade.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and outcome assessors are unaware 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 Ardabil University of Medical Sciences
Street address
Daneshghah Street
City
Ardabil
Province
Ardabil
Postal code
561577664
Approval date
2019-08-10, 1398/05/19
Ethics committee reference number
1398.242.IR.ARUMS.REC
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
cough
Timepoint
Before and after the intervention
Method of measurement
Medical examination
Secondary outcomes
1
Description
Fever
Timepoint
Before and after the intervention
Method of measurement
Thermometer
2
Description
wheezing
Timepoint
Before and after the intervention
Method of measurement
Medical Examination
Intervention groups
1
Description
Intervention group: For one month, the dried thyme extract will be given a dose of 1 to 4 grams per kilogram per day in 3 divided doses along with routine medical treatment.
Category
Treatment - Drugs
2
Description
Control group: Control group will receive only routine medical treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Elnaz Eskandarpour
Street address
Moallem Street
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۳۶۴۳۱۹۷
Phone
+98 45 3325 2251
Email
e.eskandarpour@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahab Bohlooli
Street address
Daneshhah Street
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 3352 2247
Email
s.bohlooli@pharmacy.arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Elnaz Eskandar pour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Moallem Street
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 3325 2251
Email
e.eskandarpour@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Elnaz Eskandar pour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Moallem Street
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۳۶۴۳۱۹۷
Phone
+98 45 3325 2251
Email
e.eskandarpour@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Elnaz Eskandar pour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Moallem Street
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۳۶۴۳۱۹۷
Phone
+98 45 3325 2251
Email
e.eskandarpour@arums.ac.ir
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
Not applicable
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