Objectives:
The aim of this study is the comparison of the effect of honey and diphenhydramine on children's nocturnal cough and sleep quality in coughing children and their parents.
Design:
In the present study, 150 children with nocturnal viral cough are chosen and will be divided randomly into 3 groups: 2 Honey groups (type 1 and 2) and Diphenhydramine group.
Setting and conduct:
Before starting the treatment, a questionnaire with 5 questions about children’s nocturnal cough and the quality of night sleep (both in children and their parents) will be given to the parents. After two days of treatment (honey or diphenhydramine) the same questionnaire will be completed by calling parents.
Major Inclusion and Exclusion criteria:
The presence of nocturnal viral cough during the last week and absence of pnemonia and asthma symptoms and baseline disease.
Intervention:
Recieving honey or diphenhydramine
Main outcome measures (variables):
Finally the first and second answers will be compared to each other for comparison of the effect of honeys and diphenhydramine on the severity and frequency and bothering of children's nocturnal cough.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090819037N1
Registration date:2014-10-10, 1393/07/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-10, 1393/07/18
Registrant information
Name
Mahdieh Yousef-Zanjani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
yusefi.mahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Qazvin university of medical sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Two Kinds of Iranian Honey and Diphenhydramine on Nocturnal Cough and Sleep Quality in Coughing Children and Their Parents
Public title
Comparison of the Effect of Honey and Diphenhydramine on Children's Nocturnal Cough and Sleep Quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of cough with or without rhinorrhea for at most 7 days; Congestion; fever (oral temperature less than 39˚); pharyngitis; malaise; headache
Exclusion criteria:
Presence of asthma; pneumonia; laryngotracheobronchitis; sinusitis; allergic rhinitis; baseline disease; frequent hospitalization; recent consuming of diphenhydramine
Age
From 2 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients who come to the pediatrics clinic will be randomly selected for each groups of the study by Random Allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin university of medical sciences
Street address
Shahid Bahonar blv.
City
Qazvin
Postal code
Approval date
2013-10-15, 1392/07/23
Ethics committee reference number
28.20.7932
Health conditions studied
1
Description of health condition studied
nocturnal cough due to acute upper respiratory tract infection
ICD-10 code
J06.9
ICD-10 code description
upper respiratory infection (acute)
Primary outcomes
1
Description
Severity of children's nocturnal cough
Timepoint
up to 48 hours of treatment
Method of measurement
Same questionnaire before and after the treatment
2
Description
Frequency of children's nocturnal cough
Timepoint
up to 48 hours of treatment
Method of measurement
Same questionnaire before and after the treatment
3
Description
The bothersome nature of children's nocturnal cough
Timepoint
up to 48 hours of treatment
Method of measurement
Same questionnaire before and after the treatment
Secondary outcomes
1
Description
The quality of nocturnal sleep in patients' parents
Timepoint
up to 48 hours of treatment
Method of measurement
Same questionnaire before and after the treatment
2
Description
The quality of nocturnal sleep in patients
Timepoint
up to 48 hours of treatment
Method of measurement
Same questionnaire before and after the treatment
Intervention groups
1
Description
Control group:
Oral solution of Diphenhydramine HCl from Ramopharmin drug manufacturing company, Tehran, Iran, registered No. 1228056772
(Patients in this group receive their treatments within 30 minutes before going to sleep at two subsequent nights (two doses).
Dosage: children aged 2 to 6 years receive 6.25 mg/dose (2.5 mL), children aged 6 to 12 years receive 12.5 mg/dose (5 mL)).
Category
Treatment - Drugs
2
Description
First intervention group
Kimia Honey from Kimia company, Ardabil, Iran, registered No. 4916
(Patients in this group receive their treatments within 30 minutes before going to sleep at two subsequent nights (two doses).
Dosage: children aged 2 to 6 years receive 6.25 mg/dose (2.5 mL), children aged 6 to 12 years receive 12.5 mg/dose (5 mL)).
Category
Treatment - Drugs
3
Description
Second intervention group:
ShahdeGolha Honey from ShahdeGolha company, Khorasan-e Razavi, Iran, registered No. 73294
(Patients in this group receive their treatments within 30 minutes before going to sleep at two subsequent nights (two doses).
Dosage: children aged 2 to 6 years receive 6.25 mg/dose (2.5 mL), children aged 6 to 12 years receive 12.5 mg/dose (5 mL)).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Pediatrics Hspital
Full name of responsible person
Dr. Parviz Ayazi
Street address
Qods Square
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Shahid Bahonar Boulevard
City
Qazvin
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahdieh Yousef-Zanjani
Position
Medical Student
Other areas of specialty/work
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
Phone
+98 912 614 3161
Fax
Email
yusefi.mahdieh@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)