Protocol summary

Study aim
Comparision between the effectiveness of a syrup made from sweet Almond with Diphenhydramine in the frequency and severity nocturnal cough due to upper respiratory tract infection (common cold) in children from 2 to 12 years
Design
Randomized clinical trials with community-based and pragmatic control group, with parallel groups, without blinding
Settings and conduct
Listed 60 patients with cough due to upper respiratory tract infection(common cold) who have entered the research criteria from the Rasul-e-Akram Hospital and Likert scale check list completed and randomly divided into 2 groups of 30 people
Participants/Inclusion and exclusion criteria
Inclusion criteria: presence of cough for at most 7 days with or without congestion; fever ( 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.
Intervention groups
Intervention group: the oral syrup from sweet almond (equivalent to the dose of Diphenhydramine syrup received in the control group: 1 mg/ kg ) will be prescribed in 1 Dose half an hour before bedtime. Control group: Diphenhydramine syrup (Al Havi®) will be prescribed 1 mg/kg/dose in 1 Dose half an hour before bedtime. Duration of treatment is 2 nights in both groups.
Main outcome variables
Cough frequency; cough severity; child sleep quality; parents' sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180527039867N1
Registration date: 2018-06-13, 1397/03/23
Registration timing: prospective

Last update: 2018-06-13, 1397/03/23
Update count: 0
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Zahra Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5558 0388
Email address
karimi.z@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of a syrup made from sweet Almond in pediatric nocturnal cough with upper respiratory tract infection(common cold) compared to Diphenhydramine: A randomized clinical trial
Public title
Evaluation the effect of syrup made from sweet Almond in pediatric nocturnal cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients's age is two to twelve years old Cough due to upper respiratory tract infection (common cold) for less than 7 days Concomitant symptoms (mild fever: less than 39 ° C, sore throat, cramps, rhinorrhea, mild headache, feeling tired, sneezing Do not use any anti-cough product 18 hours before the intervention Lack of underlying disease (asthma, allergic rhinitis, sinusitis, laryngo tracheobronchitis, congenital heart disease, chronic lung disease, diabetes, kidney disease) Conscious written consciously from parents to enter the study Possibility of patient Follow up
Exclusion criteria:
Children with signs and symptoms of asthma, pneumonia, allergic rhinitis, sinusitis, laryngo tracheobronchitis, congenital heart disease, chronic lung disease, diabetes, kidney disease The onset of symptoms of otitis, sinusitis, onset of symptoms of of the lower respiratory tract infection , the addition of a bacterial infection to the viral infection (edema, respiratory problem, severe sore throat with painful ingestion, nausea, vomiting, fever above 39 °, septic nasal discharge, Facial and peri orbital pain) during the intervention Lack of allergy (presence of symptoms such as i itchy eye & nose, a history of prolonged cold periods,history of repeating similar symptoms, positive family history of allergy, history of drug and food allergy), The presence of sign and symptoms of a Reactive Airway Disease including: tachypnea and tachycardia, short breath, chest tightness ) Getting any anti cough drug before intervention Not using or using irregularly recommended medications Add other cough drugs to treatment during the intervention allergic reaction to drug combinations during the study disrelish to cooperate until the end of the study Inaccessibility of the patient during the study
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization based on random numbers
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 Iran University of Medical Sciences
Street address
Fifth Floor, Headquarters, Hemet Highway Between Chamran and Sheikh Fazlullah, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-05-30, 1397/03/09
Ethics committee reference number
IR.IUMS.REC 1396.9421309005

Health conditions studied

1

Description of health condition studied
Cough due to upper respiratory tract infection(common cold)
ICD-10 code
J06
ICD-10 code description
Acute nasopharyngitis [common cold]

Primary outcomes

1

Description
Cough frequency
Timepoint
At the beginning of the study, the first and second day of intervention
Method of measurement
Likert scale Checklist

2

Description
Cough severity
Timepoint
At the beginning of the study, the first and second day of intervention
Method of measurement
Likert scale Checklist

3

Description
Nightly sleep quality of the child
Timepoint
At the beginning of the study, the first and second day of intervention
Method of measurement
Likert scale Checklist

4

Description
Nightly sleep quality of the parent
Timepoint
At the beginning of the study, the first and second day of intervention
Method of measurement
Likert scale Checklist

Secondary outcomes

1

Description
Time Control Signs
Timepoint
Any time during the study
Method of measurement
Report by the child's parents

Intervention groups

1

Description
Intervention group: The oral syrup from sweet almond (equivalent to the dose of Diphenhydramine syrup received in the control group: 1 mg/ kg ) will be prescribed in 1 Dose half an hour before bedtime.Duration of treatment is 2 nights
Category
Treatment - Drugs

2

Description
Control group: Diphenhydramine syrup (Al Havi®) will be prescribed 1 mg/kg/day in 1 Dose half an hour before bedtime.Duration of treatment is 2 nights.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Zahra Karimi
Street address
Sattar Khan St. Mansoori St , Rasoul-e-Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
karimi.z@tak.iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mazaher Negad
Street address
Islamic Medicine and Supplement , Institute of Medical History Studies, No. 9, Pirnia Alley, Laleh Zar North Street (Laleh Zar Nou), Islamic Republic. Street,
City
Tehran
Province
Tehran
Postal code
1145847111
Phone
+98 21 5515 2191
Email
imhicmr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Zahra Karimi
Position
Iranian medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 847 , Vahdat-e-Islami St , South side of Park City , Hassan Abad Square, Behesht Street, Faculty of Iranian Medicine
City
Tehran
Province
Tehran
Postal code
114733311
Phone
+98 21 5558 0388
Email
karimi.z@tak.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Omid Sadeghpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Iranian Medicine, 847,Behesht Street,South side of Park City,Vahdat-e-Islami St.,, Hassan Abad Square,tehran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
o.sadegh33@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Karimi
Position
Iranian medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, 847,Behesht Street,South side of Park City,Vahdat-e-Islami St.,, Hassan Abad Square,tehran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
karimi.z@tak.iums.ac.ir

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
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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