the goal of this study is a Comparison of anti-seizure effect carbamazepine and valproate sodium with monotherapy in treatment seizure in adults.inclusion criteria is:people with 18 years; who that not treatment with anti seizure drugs and exclusion criteria is:people with-18 years; pegnancy; hysterical seizure or metabolic seizure; who that dont have adhesion.126 adult patients who suffered from seizures in the neurology clinic at valie asr haspital were studiy.randomely devide in two groups, one receiving monotherapy with carbamazepine and the others with valproate sodium.primary outcome measur is side effects of bothe drugs and treatment of seizure
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050717611N1
Registration date:2014-05-19, 1393/02/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-19, 1393/02/29
Registrant information
Name
Roohola Eshghi kajghane
Name of organization / entity
Birjand University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5256 2403
Email address
rooheeshghi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University Of Medical Sciences
Expected recruitment start date
2014-05-15, 1393/02/25
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of Anti-seizure Affect Carbamazepine And Valproate Sodium With Monotherapy In Treatment Seizure In Adults
Public title
Comparison Of Anti-seizure Affect Carbamazepin And Valproat Sodium In Treatment Seizure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:People with 18 years; who that not treatment with anti seizure drugs; dont have history off cva. Exclusion criteria:People with-18 years; pegnancy; cva and cerebral tumor; hysterical seizure or metabolic seizure; who that dont have change in eeg; who that dont have adhesion
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
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
Birjand University Of Medical Sciences
Street address
Birjand University Of Medical Sciences؛ Street Of Shahid Ghaffari
City
Birjand
Postal code
Approval date
2014-04-19, 1393/01/30
Ethics committee reference number
930130a87
Health conditions studied
1
Description of health condition studied
EPILEPSY
ICD-10 code
g41
ICD-10 code description
Status epilepticus
2
Description of health condition studied
Seizure
ICD-10 code
g40
ICD-10 code description
epilepsy
Primary outcomes
1
Description
Outbreak Of Seizure
Timepoint
Start Of Treatment, Secondary week, First Month,Third Month, Fifth Month
Method of measurement
Clinical Examination, Eeg
Secondary outcomes
1
Description
overweight
Timepoint
Start Of Treatment, First Month, Second Month, Fifth Month
Method of measurement
Clinical Examination
2
Description
vomiting
Timepoint
Start Of Treatment, First Month, Second Month, Fifth Month
Method of measurement
Clinical Examination
3
Description
epidermal side affect
Timepoint
Start Of Treatment, First Month, Second Month, Fifth Month
Method of measurement
Clinical Examination
4
Description
headache
Timepoint
Start Of Treatment, First Month, Second Month, Fifth Month
Method of measurement
Clinical Examination
5
Description
diplopia
Timepoint
Start Of Treatment, First Month, Second Month, Fifth Month
Method of measurement
Clinical Examination
6
Description
vertigo
Timepoint
Start Of Treatment, First Month, Second Month, Fifth Month
Method of measurement
Clinical Examination
Intervention groups
1
Description
Group That Treat With Valproate Sodium, Tablet Valproate Sodium, 200 Mg, Bid, Oral, For 5 month
Category
Treatment - Drugs
2
Description
Group That Treat Whith Carbamazepin, Carbamazepin, Tab 200 Mg ,Bid, For 5month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Rohollah Eshghi Kejghaneh
Street address
Vali Asr Hospital؛ Street Of Shahid Ghaffari
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University Of Medical Sciences
Full name of responsible person
Mr.Dr Namaie
Street address
Birjand University Of Medical Sciences؛ Street Of Shahid Ghaffari
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Vali Asr Hospital
Full name of responsible person
Rohollah Eshghi Kejghaneh
Position
Medicine Student/Intern
Other areas of specialty/work
Street address
Vali Asr Hospital؛ Street Of Shahid Ghaffari
City
Birjand
Postal code
Phone
+98 53 2824 2089
Fax
Email
Rooheeshghi@gmail.com, Rooheeshghi@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University Of Medical Sciences
Full name of responsible person
Dr Hamidreza Riasi
Position
Neurology
Other areas of specialty/work
Street address
Birjand University Of Medical Sciences؛ Street Of Shahid Ghaffari
City
Birjand
Postal code
Phone
+98 53 2824 2089
Fax
Email
Riasi_h@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University Of Medical Sciences
Full name of responsible person
Rohollah Eshghi
Position
Intern
Other areas of specialty/work
Street address
City
Birjand
Postal code
Phone
Fax
Email
Rooheeshghi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)