Epilepsy is one of the most common and chronic disease of central nervous system. Prevalence of epilepsy is 0.5-1/100 populations. Despite the recent developments in treatment of epilepsy and use new antiepileptic drugs, suggested more than 50 million populations of world have active epilepsy. Between 20-30% of patients don't have a good response to drugs.The aim of this study is better control of intractable epilepsy by foods (add chargeable amino acides). I will evaluate the effects of Glutamic acide, lyzine and arginine ( 3 time of daily need) at mornings for two weeks. Inclusion criteria's are the epileptic patients which did't response to anti convulsant drugsy , at least passed one year after diagnosis, the patients selected who have 2-3 seizure per week despite used anticovulsant drugs (poly therapy) and the end signed the consent from . Exclusion criteria are: The patients have other disorder,pregnant women,viral infections, side effects and non-corporative patients. The frequency of seizure calculate by patients or one of family member every day, and then compared the number of attacks one week before starting, first week after starting and second week after starting. The data analyzed descriptively and some findings have compared by T test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112178436N1
Registration date:2012-03-03, 1390/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-03, 1390/12/13
Registrant information
Name
Hossein Ali Ebrahimi
Name of organization / entity
Neurology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 34 1246 7500
Email address
hebrahimi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2012-02-01, 1390/11/12
Expected recruitment end date
2013-02-01, 1391/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of chargeable amino acids effects on intractable epileptic patients
Public title
Evaluation of chargeable amino acids effects on intractable epileptic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: all epileptic patients that do not have any responce to antiepileptic drug.
Exclusion criteria: pregnant women; lactating women; history of psychiatric diseas; viral infection and other seriuos diseases.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chanceler of research - Kerman University of medical sciences
Street address
Jahad Cross way
City
Kerman
Postal code
Approval date
2011-12-21, 1390/09/30
Ethics committee reference number
90/373/K
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy
Primary outcomes
1
Description
Epileptic attacks
Timepoint
Two weeks
Method of measurement
Number of attacks
Secondary outcomes
1
Description
The number of seizure attacks
Timepoint
For three weeks ( one before and one in first week an other in second week)
Method of measurement
The number of seizure attacks reported by patients or family
Intervention groups
1
Description
Group 3 (10patients) recived Arginine (three times of daily needs) for two weeks before breakfast.
Category
Treatment - Drugs
2
Description
Intractable epileptic patients have studdied. Group 1(10 patients) recieved Glutamic acid (Three times of daily needs) for two weeks every morninig before breakfast .
Category
Other
3
Description
Group 2 (10 patients) reicived Lyzine (three times of daily needs) for two weeks befor break fast
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Medical Center
Full name of responsible person
Dr Hossein Alli Ebrahimi
Street address
Blvd. Kosar
City
Kerman
2
Recruitment center
Name of recruitment center
Dr. Hossein Ali Ebrahimi Office
Full name of responsible person
Dr. Hossein Ali Ebrahimi
Street address
Esteghlal Building - Esteghlal Avenue
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neurology Research Center
Full name of responsible person
Dr Hossein Ali Ebrahimi
Street address
Blvd. kosar
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neurology Research Center
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
Research office
Full name of responsible person
Gholam Reza Sepehri
Position
Manager
Other areas of specialty/work
Street address
Jahad Cross way
City
Kerman
Postal code
Phone
+98 21 15780
Fax
Email
gsepehri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neurology research center
Full name of responsible person
Dr Hossein Ali Ebrahimi
Position
Head of center
Other areas of specialty/work
Street address
Blvd. Kosar
City
Kerman
Postal code
7618751151
Phone
+98 34121157809
Fax
+98 34 1246 7500
Email
ebrahimi.ha@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Neurology Research Center
Full name of responsible person
F. Ashrafi nia
Position
Manager
Other areas of specialty/work
Street address
Blvd. Kosar
City
Kerman
Postal code
7618751151
Phone
+98 34121157809
Fax
+98 34 1211 5803
Email
ashrafifarzaneh60@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)