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Evaluation of the effect of L-arginine on patiant with refractory epilepsy

Protocol summary

Summary
Epilepsy is one of the world’s most common non-transmissible disorders. Estimated 50 million persons are involved worldwide. Nearly 20-30% of these patients do not show desirable responses to antiepileptic drugs. In Kerman, 8/1000 populations need to use antiepileptic drugs. This study was aimed at investigating the effects of L-Arginine on the frequency and duration of attacks for refractory epileptic patients (two epileptic attacks every month after combination therapy by 2 or more antiepileptic drugs, simultaneously). Method: this study is double blind. Subsequent to obtaining informed consent, the patients were randomly divided into the two groups of intervention and control (21 subject to each group); the interventional group received l-arginine pills, twice the daily requirement, for three months, and the control group received pills containing starch, molded similar to l-arginine pills, as placebo for three months. Neither the patients nor the attending physician knew which patient received l-arginine or starch pills. The number and intensity (duration) of attacks were questioned from the patient or his/her carer and recorded in the specifically prepared questionnaire, once prior to taking the medicine or placebo, and again during treatment. After three months, the data, including seizure frequency was analyzed. The Adverse effects was also analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201603078436N3
Registration date: 2016-04-29, 1395/02/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-29, 1395/02/10
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
Neurology Research Center - Kerman University of Medical Sciences
Expected recruitment start date
2016-04-02, 1395/01/14
Expected recruitment end date
2017-01-18, 1395/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of L-arginine on patiant with refractory epilepsy
Public title
Effect of L arginine on epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion : patients with epilepsy who have not responses to combination therapy(at least 2 attack per month) by antiepileptic drugs (at least 2 drugs); Exclusion: any disorders except epilepsy; Neurologic disorder except epilepsy; Pregnancy; hypersensitivity or adverse events to L-rrginine
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Jomhory Eslami Blvd
City
Kerman
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
IR.kmu.REC.1394.515

Health conditions studied

1

Description of health condition studied
epilepsy
ICD-10 code
G40
ICD-10 code description

Primary outcomes

1

Description
Number of epileptic attacks
Timepoint
Duration of every attack in one month
Method of measurement
number

2

Description
severity of attacks
Timepoint
duration every attack
Method of measurement
number

Secondary outcomes

1

Description
non-tolerance
Timepoint
3 months
Method of measurement
report

Intervention groups

1

Description
L-arginine 2 size of daily need every day for three months
Category
Treatment - Drugs

2

Description
placebo(starch) 3-6 tablets every day for three months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Medical Center + Neurologic clinic of Kerman University of medical sciences
Full name of responsible person
Habibeh Mola Mohammadi
Street address
Kosar Blvd
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neurology Research Center Kerman University of Medical Sciences
Full name of responsible person
Elham Khadir
Street address
Kosar Blvd.
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 Kerman 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
Research manager of Kerman university of medical sciences
Full name of responsible person
Mahdi Ansari
Position
Pharmacy Professor
Other areas of specialty/work
Street address
Somaeh cross way
City
Kerman
Postal code
Phone
+98 34 3226 3815
Fax
Email
mansari@yahoo.co
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neurology Research Center Kerman University of Medical Sciences
Full name of responsible person
Hossein Ali Ebrahimi Meimand M.D
Position
Professor of Neurology
Other areas of specialty/work
Street address
Neurology Research Center Kosar Blvd
City
Kerman
Postal code
Phone
+98 34 3212 4727
Fax
Email
hebrahimi@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Afzali Pour Faculty
Full name of responsible person
Habibeh Mola Mohammadi
Position
Student
Other areas of specialty/work
Street address
Afzali Pour Faculty - Kerman
City
Kerman
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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