The effect of almond syrup in the treatment of primary sleep disorders in children 6 to 12 years admitted to hospital in the first quarter of 1395 Ziaeian
This study is designed to evaluate the effect of almond syrup in the treatment of primary dysomnia in children aged 6 to 12 years.All the children admitted to pediatric clinics who has the inclusion criteria were enrolled in the study.40 children randomized in two groups and all received 15 ml of a syrup including almond and only preservative substance as placebo.BEARS scoring will be evaluated and mean of scoring will be analyzed tn two groups after 3 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021326484N2
Registration date:2016-03-09, 1394/12/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-09, 1394/12/19
Registrant information
Name
Ghazal Shariat Panahi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 5448
Email address
gh-shariatpanahi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences Research Grant Scheme
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of almond syrup in the treatment of primary sleep disorders in children 6 to 12 years admitted to hospital in the first quarter of 1395 Ziaeian
Public title
The effect of almond syrup in the treatment of sleep disorders in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: sleep disturbance in the form of dyssomnya : children 6-12 years
Exclusion criteria :any psychiatric underlying disease :cerebral palsy: thyroid disorders : drug use
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
School of Medicine Poor Sina AVE Keshavarz street
City
Tehran
Postal code
1417613151
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
IR.TUMS.REC.1394.1364
Health conditions studied
1
Description of health condition studied
PRIMARY DYSSOMNIA
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
BEARS questionair score
Timepoint
weekly
Method of measurement
questionair scoring
Secondary outcomes
empty
Intervention groups
1
Description
In this clinical trial study we prescribed 15ml of almond syrup to one group .
Category
Treatment - Drugs
2
Description
In control group we will prescribe 15 ml of a syrup with similar taste and smell that contains only preservative substance
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaian hospital
Full name of responsible person
Ghazal Shariat Panahi MD
Street address
Ziaian hospital Aboozar square Tehran Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences Pardis International Campus
Full name of responsible person
Abbas Shakoori MD
Street address
Poor Sina AVE; Pardis International Campus
City
Tehran
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 Pardis International Campus