Determination of the effect of camel milk on spirometric parameters of children aged over 6 years with asthma who refer to Doctor Sheikh Hospital
Design
This clinical trial is randomized and performed on 50 patients aged over 6 years (25 people in each group) without blinding and consists of control and parallel groups
Settings and conduct
This clinical trial is conducted on patients with asthma who refer to Doctor Sheikh Hospital in Mashhad. Patients will be provided with necessary advice on avoiding allergen (edible and inhalable) orally and in written form. Patients are randomly assigned to 2 groups. Control group receives medication treatment and the second group, in addition to the medication treatment, receives 200 cc of pasteurized camel milk daily for 2 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children aged over 6 years with asthma classified as ''not well control'' in spirometry according to Nelson's book, Forced Expiratory Volume in First Second (FEV1) is 60-80% and Forced Expiratory Volume in First Second/Forced Vital Capacity (FEV1/FVC) is 75-80%. Patients are under controller therapy. Patients are not under asthma attack. Exclusion criteria: Asthma attack during the investigation period, unwillingness to continue participation in the study, creation of any sensitivity and intolerance to camel milk during the course
Intervention groups
Control group: Patients will receive medication treatment (inhaled corticosteroids, montelukast and long-acting beta-agonists) according to the standard protocol.
Intervention group: In addition to medication treatment (inhaled corticosteroids, montelukast and long-acting beta-agonists), patients will receive 200 cc of pasteurized camel milk daily for 2 months.
Main outcome variables
more than 80% change in FEV1 and FEV1/FVC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170813035653N2
Registration date:2018-12-09, 1397/09/18
Registration timing:registered_while_recruiting
Last update:2018-12-09, 1397/09/18
Update count:0
Registration date
2018-12-09, 1397/09/18
Registrant information
Name
Seyed Javad Sayedi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3724 9421
Email address
sayedij@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-07, 1396/11/18
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of camel milk on spirometric parameters of children aged over 6 years with asthma
Public title
Investigation of the effects of camel milk on children with asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged over 6 years with asthma who are classified as ''not well control'' according to Nelson's book
Forced Expiratory Volume in First Second (FEV1) is 60-80% and Forced Expiratory Volume in First Second/Forced Vital Capacity (FEV1/FVC) is 75-80% in spirometry.
Patients are under controller therapy
Patients are not under asthma attack
Exclusion criteria:
Asthma attack during the investigation period
Unwillingness to continue participation in the study
Creation of any sensitivity and intolerance to camel milk during the course
Age
From 6 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to either control or intervention groups according to a random number table provided by a computer (simple randomization).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
IR.MUMS.fm.REC.1396.555
Health conditions studied
1
Description of health condition studied
Asthma in children
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Percentage of people whose Forced Expiratory Volume in First Second (FEV1) exceeds 80%
Timepoint
At the beginning of the study (before the intervention) and two months after beginning drug use (after the intervention)
Method of measurement
spirometer device
2
Description
Percentage of people whose Forced Expiratory Volume in First Second/Forced Vital Capacity (FEV1/FVC) exceeds 80%.
Timepoint
At the beginning of the study (before the intervention) and two months after beginning drug use (after the intervention)
Method of measurement
spirometer device
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients will receive medication treatment (inhaled corticosteroids, montelukast and long-acting beta-agonists) according to the standard protocol.
Category
Treatment - Drugs
2
Description
Intervention group: In addition to medication treatment (corticosteroids, montelukast and long-acting beta-agonists according to the standard protocol), patients will receive 200 cc of pasteurized camel milk daily for 2 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Sheikh hospital
Full name of responsible person
Dr seyed Javad Sayedi
Street address
Dr Sheikh hospital, Taheri Ave, Tohid Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3727 3943
Email
SayediJ@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr seyed Javad Sayedi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr Sheikh hospital, Taheri Ave, Tohid Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3727 3943
Email
SayediJ@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr seyed Javad Sayedi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr Sheikh hospital, Taheri Ave, Tohid Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3727 3943
Email
SayediJ@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr seyed Javad Sayedi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr Sheikh hospital, Taheri Ave, Tohid Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3727 3943
Email
SayediJ@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.