Protocol summary

Study aim
Comparison of the effect of a product made from violet oil 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
Among the patients referred to the pediatric clinic of Ali Asghar Hospital, 60 patients with cough due to upper respiratory tract (cold) infection who met the inclusion criteria will be selected and the Likert checklist will be completed and they will be randomly assigned into two group of 30.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cough for up to 7 days with or without the following: nasal congestion; Fever below 39 ° C; Sore throat; Lethargy; Headache; Exclusion criteria: asthma; Pneumonia; Laryngotracheobronchitis; Sinusitis; allergic rhinitis; Background disease; Frequent hospitalization; Recent use of diphenhydramine
Intervention groups
Intervention group The product is made of violet oil (topically applied on the sternum and 2 cm around it) twice daily. Diphenhydramine syrup control group is produced by Alhavi Pharmaceutical Company for children 2 to 5 years 2.5 mg and children 5-12 years 5 mg every 8 hours.The duration of treatment for both groups is two days.
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: IRCT20191127045522N1
Registration date: 2020-03-30, 1399/01/11
Registration timing: prospective

Last update: 2020-03-30, 1399/01/11
Update count: 0
Registration date
2020-03-30, 1399/01/11
Registrant information
Name
Ali Jabbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5558 0388
Email address
mralijabari1358@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of violet oil preparation on the frequency and severity of nocturnal cough in children aged 2 to 12 years with upper respiratory tract infection (common cold) compared to diphenhydramine: a randomized clinical trial
Public title
Evaluation of efficacy of violet oil preparation in nocturnal cough in children with upper respiratory tract infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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 Age 2 to 12 years Having the desire and consent for intervention
Exclusion criteria:
Frequent admission in hospital Children with signs and symptoms of asthma, pneumonia, allergic rhinitis, sinusitis, laryngo tracheobronchitis, congenital heart disease, chronic lung disease, diabetes, kidney disease Allergies before entering the study (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
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
Randomization uses the randomization block method, all possible modes of quadratic blocks are determined from two interventions A and B, quadratic blocks are selected using a random number table. A randomization list will then be prepared which will be assigned to individuals from 1 to 60 interventions according to this list.
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
2019-10-09, 1398/07/17
Ethics committee reference number
IR.IUMS.REC.1398.720

Health conditions studied

1

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

2

Description of health condition studied
cough
ICD-10 code
R05
ICD-10 code description
Cough

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 to control symptoms
Timepoint
Any time during the study
Method of measurement
Report by the child's parents

Intervention groups

1

Description
Intervention group: Product made from violet oil topically applied on chest 2 times. Duration of treatment is 2 days
Category
Treatment - Drugs

2

Description
Control group: Diphenhydramine syrup is produced by Alhavi Pharmaceutical Company at a dose of 1.5 mg every 8 hours for children 2 to 5 years, and 2.5 mg every 8 hours for children 5 to 12 years.The treatment duration is two nights
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Children's Hospital
Full name of responsible person
Ali Jabbari
Street address
Ali Asghar Children's Hospital., Shahid Vahid Dastgerdi Street (formerly Zafar)., Modarres Highway
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2045
Email
mralijabari1358@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Amir Hossein Jamshidi
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
Ali Jabbari
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
1147333111
Phone
+98 21 5558 0388
Email
mralijabari1358@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Omid Sadeghpor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
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
1147333111
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
Ali Jabbari
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
1147333111
Phone
+98 21 5558 0388
Email
mralijabari1358@gmail.com

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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