The effect of Viola Syrup with acetaminophen syrup in comparison to acetaminophen syrup and placebo on the fever of children A Randomized and double blind clinical trial
Anti-fever effect of violet syrup with acetaminophen syrup on children with fever compared to acetaminophen syrup
Design
Double-blind, randomized block
Settings and conduct
Outpatient Referred to Pediatrician Pediatric Clinic, Double Blind (Patient and Physician)
Participants/Inclusion and exclusion criteria
Entry requirements:Children aged 3 to 7 years with fever below 39 ° C (outpatient) referred to outpatient setting; Exclusion: Diabetic children with a history of seizure or family history of seizures, history of febrile convulsion, antibiotic recipients, history of asthma, chronic respiratory disease, congenital diseases
Intervention groups
Children 3-7 years old with acetaminophen syrup and violet syrup, children 3-7 years old with acetaminophen and placebo syrup
Main outcome variables
Body temperature
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190409043215N1
Registration date:2020-07-08, 1399/04/18
Registration timing:registered_while_recruiting
Last update:2020-07-08, 1399/04/18
Update count:0
Registration date
2020-07-08, 1399/04/18
Registrant information
Name
Ali akbar Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3464 3176
Email address
safaria@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Viola Syrup with acetaminophen syrup in comparison to acetaminophen syrup and placebo on the fever of children A Randomized and double blind clinical trial
Public title
The effect of Viola Syrup with acetaminophen syrup in comparison to acetaminophen syrup and placebo on the fever of children A Randomized and double blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 3-7years old with fever below 39 degrees Celsius(oral) referred to outpatient setting
Exclusion criteria:
Diabetic children، with a history of seizure or family history of seizures, history of febrile convulsion, antibiotic recipients, history of asthma, chronic respiratory disease, congenital diseases
Age
From 3 years old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by block method، Initially, all 4 blocks consisting of two codes B and A (6 blocks) are then selected by random number table with random blocks selected.These blocks form a sequence equal to the sample size of codes B and A, each assigned randomly to one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are blindly coded uniformly, with the participant, clinician, and physician unaware of their content.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Deputy of Research, Shahid Saffarian Alley, 45 meters Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.ABZUMS.REC.1398.219
Health conditions studied
1
Description of health condition studied
Fever, unspecified
ICD-10 code
R50.9
ICD-10 code description
Fever, unspecified
Primary outcomes
1
Description
Fever
Timepoint
Half an hour to the first 4 hours
Method of measurement
Thermometer
Secondary outcomes
1
Description
Reduce fever
Timepoint
Every half hour for the first 4 hours
Method of measurement
Thermometer
Intervention groups
1
Description
Intervention group: Group receiving Acetaminophen syrup and Violet syrup
Category
Treatment - Drugs
2
Description
Control group: Group receiving Acetaminophen syrup and Placebo syrup
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Porrostami Children's Clinic
Full name of responsible person
Kiomars Porrostami
Street address
Shahid Motahari Ave. Nabovvat three wayes, beside Maskan Bank , Delta building
City
Karaj
Province
Alborz
Postal code
3149779451
Phone
+98 26 3447 8835
Email
dr.porrostami1975@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Norisepehr
Street address
45m street Golshahr, Saffarian St.Deputy of Research and Technology,
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Fax
+98 26 3464 4255
Email
safariali1350@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Barij Essence Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ali Akbar Safari
Position
Manager of Health Technology Development
Latest degree
Medical doctor
Other areas of specialty/work
Pharmacology
Street address
45 m Golshahr, Saffarian St., Research and Technology Deputy
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Fax
+98 26 3464 4255
Email
safariali1350@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ali Akbar Safari
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Deputy of Research and Technology, saffarian st,Golshahr 45 metric st
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3176
Fax
Email
safariali1350@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ali Akbar Safari
Position
Director of Health Technology Development Center
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Deputy of Research and Technology, Shahid Saffarian Alley, 45 meters Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3254
Fax
+98 26 3464 4255
Email
safariali1350@yahoo.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