Background & purpose: Viral upper respiratory tract infection and cold drugs consumption in children is widespread, These drugs may not only have no effect on disease improvement, but also have many side effects. The purpose of this study was comparison of honey compare with diphehydramine effect in the alleviation of cough in children trial after 2 days of treatment, including severity and frequency remission rates.
Materials and Methods: In a double blind clinical trial study, which was conducted in 1389 at the pediatric clinic of Shariati Hospital in Bandar Abbas city, among children two to five years with symptoms of acute cough associated with viral upper respiratory tract infection symptoms, 170 children were selected and after applying the exclusion criteria (involving other parts of the respiratory system, adding a bacterial infection ...) 126 children remained in the study. The patients divided into two groups receiving honey and diphenhydramine. Two days later second examination was done and number and severity of cough in night and day was evaluated. The number and severity of nocturnal cough were compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110247882N1
Registration date:2012-11-27, 1391/09/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-27, 1391/09/07
Registrant information
Name
Mahshid Ahmadi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1320 7026
Email address
m.ahmadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences(HUMS)/ Researcher
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Study of Honey versus Diphenhydramine Effect on Cough Alleviation in 2-5 Years Old Children with Viral Upper Respiratory Tract Infection
Public title
Honey effect on cough alleviation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:The patients's age is two to five years old; Acute cough is the chief complaint;The symptoms of viral upper respiratory tract infection are the only concomitant symptoms [fever (oral temperature from 37.8to 38.5 or axillary temp from 37.2 to 37.9) rhinorrhea , sneezing, blocked nose, sore throat, cough, mild headache, restlessness, hoarseness];The patient has been brought to clinic at first or second day of begining cough;The patient has not bacterial infections symptoms of upper respiratory tract (moderate to high fever, sever sore throat with painful swallowing, severe headache, nausea, vomiting, abdominal pain, ...);The patient has not the symptoms of lower respiratory tract infection (high fever, chills, dyspnea, malaise, pleuritic chest pain, tachypnea, retraction); There are not associated infections such as otitis and sinusitis; Allergy is not considered ( associated symptoms such as itchy eye & nose, history of repeating similar symptoms, a history of prolonged cold periods, positive family history; The patient has not signs of Reactive Airway Disease (wheezing, shortness of breath,pressure or tightness feeling in chest , tachypnea, tachycardia); The parents have not begun any drug before coming to clinic . Exclusion criteria were: Onset of otitis or sinusitis symptoms; Onset of symptoms of lower respiratory tract involvement; Adding a bacterial infection, (purulent nasal discharge, high fever, difficulty breathing, Periorbital edema, facial pain); Not using of recommended treatments; Adding other drugs to recommended treatment; Non-coordinated reports of persons who take care of patients.
Age
From 2 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan university of Medical Sciences
Street address
Ostandari Blv
City
Bandar Abbas
Postal code
Approval date
2012-07-29, 1391/05/08
Ethics committee reference number
hec-91-5-1
Health conditions studied
1
Description of health condition studied
Common Cold
ICD-10 code
J00
ICD-10 code description
Acute nasopharyngitis
Primary outcomes
1
Description
Number of Night cough
Timepoint
Before intervention, 48 h after intervention
Method of measurement
Visual scale of the number of coughs
2
Description
Severity of night cough
Timepoint
Before intervention, 48 h after intervention
Method of measurement
Visual scale of severity of coughs
3
Description
The number of daily cough
Timepoint
Before intervention, 48 h after intervention
Method of measurement
Visual scale of the number of coughs
4
Description
severity of daily cough
Timepoint
Before intervention, 48 h after intervention
Method of measurement
Visual scale of severity of cough
Secondary outcomes
empty
Intervention groups
1
Description
Diphenhydramin syrup, 5mg/kg/TDS,for 48 h
Category
Treatment - Drugs
2
Description
Honey with the same volume and frequency and duration of use with diphenhydramine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Ali Shariatee Hospital
Full name of responsible person
Dr. Mahshid Ahmadi, Pediatrician, Assisstant professor
Street address
Shaheed Naser Blv
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences(HUMS)
Full name of responsible person
Mrs Ghasemi
Street address
Ostandari Blv
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Sciences(HUMS)
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
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mahshid Ahmadi
Position
Pediatrician/Assisstant professor
Other areas of specialty/work
Street address
Gamero building, Soltan tooye st, Velayat st, Saade Salman Sq
City
Sari
Postal code
4818914799
Phone
+98 15 1320 7026
Fax
+98 15 1354 3248
Email
mshahmadi@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mahshid Ahmadi
Position
Pediatrician/Assisstant professor
Other areas of specialty/work
Street address
Gameron building, Soltan Tooye st, Velayat st, Saade Salman Sq
City
Sari
Postal code
4818914799
Phone
+98 15 1320 7026
Fax
+98 15 1354 3248
Email
mshahmadi@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mahshid Ahmadi
Position
Pediatrician/Assisstant professor
Other areas of specialty/work
Street address
Gameron building, Soltan Tooye st, Velayat st, Saade Salman sq
City
Sari
Postal code
4818914799
Phone
+98 15 1320 7026
Fax
+98 15 1354 3248
Email
mshahmadi@yahoo.com
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)