Evaluating thyme extract effect on clinical symptoms of children with allergic rhinitis referred to allergy clinics of Urmia University of Medical Sciences
Determining the effect of thyme extract on the clinical symptoms of children with allergic rhinitis referred to allergy clinics of Urmia University of Medical Sciences.
Design
A community-based, practice-oriented, parallel-group, , randomized controlled clinical trial
Settings and conduct
This study is carried out in the children's department of Taleghani Hospital. This study will be conducted in a double-blind manner, and patients and treatment nurses will be blinded to the type and allocation of interventions. The method of blinding will be the uniformity of shape, size, color and taste in the study group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children aged 6 to 12 years old with allergic rhinitis referred to allergy clinics of Urmia University of Medical Sciences. Failure to enter: children should receive other medicine for treatment, except for thyme and Mumtazoon intranasal spray; Children whose rhinitis is caused by non-allergic causes, as well as children who experience moderate to severe drug symptoms and complications during the intervention; And also children with other systemic diseases such as sinusitis and vautitis
Intervention groups
Intervention group: 10 cc of oral thyme extract daily for 2 months. Control group: Nasal spray Mometasone.
Main outcome variables
Reduction of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150426021944N3
Registration date:2023-03-19, 1401/12/28
Registration timing:prospective
Last update:2023-03-19, 1401/12/28
Update count:0
Registration date
2023-03-19, 1401/12/28
Registrant information
Name
Hamidreza Houshmand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 7288
Email address
hamidreza.houshmnd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating thyme extract effect on clinical symptoms of children with allergic rhinitis referred to allergy clinics of Urmia University of Medical Sciences
Public title
Evaluating thyme extract effect on clinical symptoms of children with allergic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age lower than 12 years old
The use of thyme medicine and intranasal spray are excellent
Exclusion criteria:
Not using thyme medicine and Mumtazoon intranasal spray
Patients with non-allergic rhinitis
Children with moderate to severe drug side effects
Children suffering from other systemic diseases such as sinusitis and vautitis
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
1
A child aged 6 to 12 with allergic rhinitis
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the 4 block method, people will be randomly divided into two equal groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences, West Azerbaijan
Street address
Vice President of Research and Technology Development, West Azarbaijan University of Medical Sciences and Medical Services, Urmia, Jihad St
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Approval date
2022-12-27, 1401/10/06
Ethics committee reference number
IR.UMSU.REC.1401.353
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.8
ICD-10 code description
Other allergic rhinitis
Primary outcomes
1
Description
Duration of hospitalization
Timepoint
Duration of treatment
Method of measurement
Length of hospitalization
Secondary outcomes
1
Description
Medical allergy
Timepoint
Duration of treatment
Method of measurement
Clinical observations
Intervention groups
1
Description
Intervention group: Thyme extract orally at a dose of 10 cc per day for 60 days
Category
Treatment - Drugs
2
Description
Control group: Nasal spray Mometasone every 12 hours as standard treatment Intervention group: 10 cc thyme extract daily in addition to standard treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital, Urmia
Full name of responsible person
Dr. Soheila Sadeghpour
Street address
Kashani street
City
Orumieh
Province
West Azarbaijan
Postal code
57159-74677
Phone
+98 44 3344 4592
Email
itc@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Houshmand
Street address
Kashani street
City
Orumia
Province
West Azarbaijan
Postal code
51159-74677
Phone
+98 44 3344 4592
Email
itc@usmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Sohila Sadeghpour
Position
Specialist assistant in children's diseases
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Kashani
City
Orumia
Province
West Azarbaijan
Postal code
57159-74677
Phone
+98 44 3344 4592
Email
soheilasadeghpourazar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
ِِDr. Hamid Reza Houshmand
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani street
City
Orumia
Province
West Azarbaijan
Postal code
57159-74677
Phone
0098 44 3334592
Email
hamidreza.houshmand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Sohila Sadeghpour
Position
Specialist assistant in children's diseases
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Kashani Street
City
Orumia
Province
West Azarbaijan
Postal code
57159-74677
Phone
+98 44 3344 4592
Email
soheilasadeghpourazar@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
No - There is not 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