Determining the effect of propranolol alone in comparison with propranolol with L-carnitine in the prophylactic treatment of cyclic vomiting syndrome in children
Design
A clinical trial, with the parallel groups, single-blinding, randomized
Settings and conduct
This randomized single-blind clinical trial study is performed in the pediatric gastrointestinal clinic of Imam Hossein Hospital. In this study, 104 children with cyclic vomiting syndrome will be included and randomly divided into 2 parallel groups. One group receives propranolol alone and the other group receives propranolol with L-carnitine tablets daily. The incidence of vomiting attacks, its severity and intervals before and during 6 months after the start of treatment will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 3 to 18 years old with cyclic vomiting syndrome who have more than two seizures in a month. Also no seizures, metabolic diseases, and gastrointestinal diseases.
Intervention groups
Intervention group 1: Patients receive propranolol tablets(Poursina Pharmaceutical Co.) at a dose of 1 mg/kg daily with L-carnitine tablets(Poursina Pharmaceutical Co.) at a dose of 50-100 mg/kg with a maximum dose of 2 g daily for three months.
Intervention group 2: Patients receive only propranolol tablets(Poursina Pharmaceutical Co.) at a dose of 1 mg/kg daily for three months.
Main outcome variables
Incidence of vomiting attacks; Severity of vomiting attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120716010297N9
Registration date:2020-08-17, 1399/05/27
Registration timing:prospective
Last update:2020-08-17, 1399/05/27
Update count:0
Registration date
2020-08-17, 1399/05/27
Registrant information
Name
Leili Allahbakhshian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7079
Email address
allahbakhshian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of propranolol alone and propranolol with L-carnitine in the prophylactic treatment of cyclic vomiting syndrome in children
Public title
The role of propranolol with L-carnitine in the prophylactic treatment of cyclic vomiting syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
cyclic vomiting syndrome with more than two attacks in a month
No seizures
No metabolic diseases
No gastrointestinal diseases
Exclusion criteria:
Age
From 3 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
First, eligible patients will be simple randomly selected. Then they will be divided into two groups of 52 using the random block method with 2 blocks. So that the first two cases are separated and assigned to group one, the second two cases are separated and assigned to group two, and this will be continued two by two in the same way till the ending of samples.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the different dosage of the drugs and the combination of the two drugs in one of the two groups, it is not possible for the researcher to be blind and the child's parents will be aware. But a statistician of the two groups will not know.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2019-12-22, 1398/10/01
Ethics committee reference number
IR.MUI.MED.REC.1398.461
Health conditions studied
1
Description of health condition studied
Cyclic vomiting syndrome
ICD-10 code
G43.A0
ICD-10 code description
Cyclical vomiting
Primary outcomes
1
Description
Incidence of vomiting attacks
Timepoint
Before and during 6 months after the start of the intervention
Method of measurement
Observation
2
Description
Severity of vomiting attacks
Timepoint
Before and during 6 months after the start of the intervention
Method of measurement
Visual scale(Score 1 lowest severity and score 10 highest severity of vomiting attacks)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients receive propranolol tablets (Poursina Pharmaceutical Co.) at a dose of 1 mg/kg daily with L-carnitine tablets (Poursina Pharmaceutical Co.) at a dose of 50-100 mg/kg with a maximum dose of 2 g daily for three months.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients receive only propranolol (Poursina Pharmaceutical Co.) at a dose of 1 mg/kg daily for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Gastroenterology Clinic of Imam Hossein Hospital
Full name of responsible person
Somayeh Janani
Street address
Imam Khomeini Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Famouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Unit 4, Parisa apartment, Alley 5, Mehrabad Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
fat.famoori@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Famouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Unit 4, Parisa apartment, Alley 5, Mehrabad Street, Isfahan.