Comparison of the effect of thymoquinone in the treatment of infants with infantile refractory spasm
Design
The clinical trial had a control and intervention group, cross-over performed, no blinding and randomization was done, and the study was a phase 3 of clinical trial, which was performed on 20 patients.
Settings and conduct
This study was performed on 20 children with refractory infantile spasm referred to the Pediatric Neurology Clinic and hospitalized in the Pediatric Neurology Department of Mashhad Ghaem Hospital, cross over and they were divided into two groups of intervention and controlwho . Oral drops of thymoquinone Take for 3 weeks and the effect of this intervention on the number of seizures in the patient is examined weekly.
Participants/Inclusion and exclusion criteria
Infants who have seizures at least 3 times a week despite receiving at least 5 days of injectable corticotropin and at least one other drug to treat infantile spasm
Intervention groups
In the intervention group, the patient is given oral drops of thymoquinone for 3 weeks and in the control group, each patient is considered as his control in terms of personal characteristics, history of past diseases, number of seizures, family history and results of cell count and Bs, AST, ALT, BUN, Cr, is checked.
Main outcome variables
Number of seizures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200131046317N2
Registration date:2021-04-15, 1400/01/26
Registration timing:prospective
Last update:2021-04-15, 1400/01/26
Update count:0
Registration date
2021-04-15, 1400/01/26
Registrant information
Name
Javad Akhondian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 7451
Email address
akhondianj@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of thymoquinone in the treatment of infants with infantile refractory spasm
Public title
The effect of thymoquinone on infantile spasm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants who, despite receiving at least 5 days of injectable corticotropin with at least one other appropriate drug for the treatment of infantile spasm, have at least 3 seizures per week as spasms or myoclonic
Parental satisfaction
Exclusion criteria:
having liver or kidney disease.
neurodegenerative disease.
Age
From 4 months old to 18 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.MUMS.fm.REC.1395.549
Health conditions studied
1
Description of health condition studied
Infantile refractory spasm
ICD-10 code
G99.8
ICD-10 code description
Other specified disorders of nervous system in diseases classified elsewhere
Primary outcomes
1
Description
Seizures numbers
Timepoint
At the beginning of the study and weekly for 3 weeks while taking thymoquinone
Method of measurement
Based on parents' reports
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Because no two patients with drug-resistant infantile spasm (in terms of underlying causes of disease, inheritance of disease, socioeconomic status and parental care and types of drugs used) are not similar, so each patient is Considered as his control and will be monitored according to the test results for Bs, AST, ALT, BUN, Cr, and cell count (these include personal characteristics, history of past illnesses, number of seizures, family history, Patient information too).
Category
Treatment - Drugs
2
Description
Intervention group: Thymoquinone drops (consumed thymoquinone powder, produced by the German company Sigma, the drug form of which is an oral drop with an alcohol base, in each cc of which there is 10 mg of the active substance thymoquinone) as an additional drug for a period of 3 weeks is given to patients along with the initial medication.The researchers contact the patients by phone weekly and ask the parents about the number of seizures, the patient's general condition and possible complications at the end of each week and record it in the patient file. Then the results will be compared with the period before prescribing and finally statistical analysis will be performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Javad Akhondian
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
akhondianj@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Javad Akhondian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ghaem hospital, Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2496
Email
akhondianj@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Javad Akhondian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2496
Email
akhondianj@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Javad Akhondian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2496
Email
akhondianj@mums.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
Not applicable
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