this study is a randomised double blind,patients and researcher, crossover clinical trial.the objective of study is assessment of Efficacy of combined extract of Nigella Sativa and Thymus Vulgaris on refractory seizures in childrenin Ahvaz city.The patients will be divided randomly into two groups.15 Patients in the intervention group receive NS and TV extract as an adjunctive therapy. 15 patients in the control group receive placebo with same shape.Then all the patients will be evaluated for two weeks (as washout period) after two months in the terms of duration and the frequency of epilepsy and side effects. Then after crossover the prepared extracts and placebo will be administrated for groups for another two months . Then the frequency and duration of seizure will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052428043N1
Registration date:2016-12-09, 1395/09/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Maryam Heydarazad Zadeh
Name of organization / entity
Ahvaz Judishapur University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 3553 0869
Email address
heydarazad.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-03-10, 1395/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of combined extract of Nigella Sativa and Thymus Vulgaris on refractory seizures in children
Public title
Efficacy of combined extract of Nigella Sativa and Thymus Vulgaris on refractory seizures in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : children with a diagnosis of refractory seizures; having at least two episodes of seizures during one month prior to study entry; regular consumption of previous antiepileptic drugs.
Exclusion criteria ; occurrence of adverse side effects such as nausea and vomiting; increase the number and duration of seizure after starting NS and TV; and dissatisfaction to continue participation in study.
Age
From 3 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur Univercity of Medical Sciences
Street address
Ahvaz ,Golestan Blv, Ahvaz Jundishapur Univercity of Medical Sciences
City
Ahvaz
Postal code
Approval date
2015-06-06, 1394/03/16
Ethics committee reference number
IR.AJUMS.REC.1394.141
Health conditions studied
1
Description of health condition studied
epilepsy
ICD-10 code
G40,G41
ICD-10 code description
Episodic and paroxysmal disorders
Primary outcomes
1
Description
seizures frequency per week
Timepoint
two months prior to study-five months during study
Method of measurement
visitable seizure scaling
2
Description
seizure duration
Timepoint
two months prior to study-five months during study
Method of measurement
visitable seizure scaling
Secondary outcomes
1
Description
side effets
Timepoint
five months
Method of measurement
visitable scaling
Intervention groups
1
Description
intervention group: patients with age 3-12 years receive 5cc of prepared extract(115 mg of extract is found in 5 cc of prepared drug) three times a day and patients with age >12 years receive 7.5 cc of prepared extract three times a day for two months. Then all the patients will be evaluated for two weeks (as washout period) after two months in the terms of duration and the frequency of epilepsy and side effects. Then the prepared placebo will be administrated foranother two months.
Category
Treatment - Drugs
2
Description
contorol group: patients with age 3-12 years receive 5cc of prepared placebo three times a day and patients with age >12 years receive 7.5 cc of prepared plasebo three times a day for two months. Then all the patients will be evaluated for two weeks (as washout period) after two months in the terms of duration and the frequency of epilepsy and side effects. Then the prepared extracts extract(115 mg of extract is found in 5 cc of prepared drug )with the same dosage as adjunctive therapy will be administrated for another two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Maryam Heydarazad Zadeh
Street address
Pediatrics Yard,Golestan Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghhi
Street address
Golestan BLV , Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Ahvaz Jundishapur University of Medical Sciences