The aim of this study was to evaluate the efficacy of orange juice with phenobarbital on its serum level as an anti-seizure drug. This double-blind clinical trial was performed on 40 patients with seizure referring to Hashemtaieh Sabzevar Educational Research Center in 1396. Patients were randomly divided into two groups. After controlling seizure with a specific intravenous phenobarbital drug (10 milligram per kilogram body weight), then to a group of phenobarbital medications with orally (2.5 milligram per kilogram body weight) with Normal water and another group was given with orange juice. Two blood samples were taken from the patient as soon as the drug was taken and then two hours after the oral dose of the drug and taken for centrifuge and then freezing into the hospital laboratory. Samples were sent to the laboratory of the School of Hygiene to determine the surface by HPLC.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062519240N3
Registration date:2017-10-21, 1396/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-21, 1396/07/29
Registrant information
Name
Omid Gholami
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4444 6070
Email address
gholamio@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2017-09-21, 1396/06/30
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of co-administration of an acid juice (Orange juice) with phenobarbital on its serum level in pediatric with seizure
Public title
Study the effect of co-administration of Orange juice with phenobarbital on its serum level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children with seizures without fever who have had seizures for the first time; Children with fever and seizures that have seizures lasting more than 15 minutes; Children with fever and seizures that have recurring seizures within 24 hours; Children with fever and seizures that have a seizure with focal manifestations
exclusion criteria: Dissatisfaction with the continuation of the plan at any stage of the plan; A child who has had a history of taking phenobarbital in the past; A child with a history of taking any anticonvulsant medication; The infant with her mother is taking a seizure that takes medicine; Children who are over 10 miligram per kilogram for lack of control of seizures receive an initial dose of intravenously.
Age
To 20 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Samples were randomly divided into case and control groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar Uniersity of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Shohada hastee street, Sabzevar, Iran
City
Sabzevar
Postal code
Approval date
2017-08-30, 1396/06/08
Ethics committee reference number
IR.MEDSAB.REC.1396.59
Health conditions studied
1
Description of health condition studied
seizure
ICD-10 code
G40
ICD-10 code description
seizure ,Epilepsy
Primary outcomes
1
Description
Serum levels of phenobarbital
Timepoint
Two hours after the intervention
Method of measurement
HPLC machine based on milligram per deciliter
Secondary outcomes
1
Description
Tonic Clonic Movement of the Patient
Timepoint
An hour after the intervention
Method of measurement
Direct observation and clinical examination
Intervention groups
1
Description
Intervention group: Phenobarbital with a dose of 2.5 milligram / kilogram body weight orally with orange juice
Category
Treatment - Drugs
2
Description
Control group: Phenobarbital with a dose of 2.5 milligram / kilogram body weight orally with normal water
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashmatyee Hospital in Sabzevar
Full name of responsible person
Morteza Tavasolizadeh
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Sabzevar University of Medical Sciences
Full name of responsible person
Mohamad Mohamadzadeh
Street address
Sabzevar University of Medical Sciences, Deputy of Research and Technology
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Sabzevar 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
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
MortezaTavasolizadeh
Position
Student
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 4464 4388
Fax
Email
Drmorteza20@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Omid Gholami
Position
Assistant Professor
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Dean of Education, Faculty of Medicine
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
dromidgholami@yahoo.com ; omidghphd@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Omid Gholami
Position
Assistant Professor
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Dean of Education, Faculty of Medicine
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
+98 51 4444 5622
Email
dromidgholami@yahoo.com ; omidghphd@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)