The aim of the present study is to determine the effect of Melatonin on sleep quality and seizure attacks in patients with intractable epilepsy
A semi clinical trial will be carried out on 30 patients with intractable seizure. Samples will be selected from neurology clinics of Arak city. After physical and neurological examination the demographic and Pittsburgh questionnaire will be fulfilled and all patients will receive melatonin 3 mg at bedtime for 2 months. Finally patients will be reexamined and for second time complete the demographic and Pittsburgh questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015013117811N7
Registration date:2015-02-11, 1393/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-11, 1393/11/22
Registrant information
Name
Shayan Amjadi
Name of organization / entity
Students Research Committee,Arak Universiry of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.amjadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
This study will be supported by a grant from Office of Vice Chancellor for Research of Arak university of Medical Sciences
Expected recruitment start date
2013-06-01, 1392/03/11
Expected recruitment end date
2014-03-01, 1392/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Melatonin in patients with intractable epilepsy
Public title
Melatonin and Epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : age 15–80 years ; clinically definitive intractable epilepsy confirmed by a neurologist ; presented to the Neurology clinics at Arak city between June, 2013 and March 2014 ; normal clinical exam ;Treatment with at least three appropriate anti-epileptic drugs had failed to control seizures in all patients
exclusion criteria : neurodegenerative disorders ; brain neoplasm ; chronic hematological , cardiac , hepatic, renal or thyroid disorder ; history of smoking and addiction to drugs or alcohol.
Age
From 15 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of medical science
Street address
Arak University of Medical Sciences ,Sardasht , Arak , Iran
City
Arak
Postal code
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
92-157-12
Health conditions studied
1
Description of health condition studied
intractable epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy
Primary outcomes
1
Description
the number of monthly seizure episodes
Timepoint
baseline and after 2 months
Method of measurement
patients self report
2
Description
Sleep quality
Timepoint
baseline and after 2 months
Method of measurement
PSQI questionaries
Secondary outcomes
empty
Intervention groups
1
Description
melatonin 3 mg nightly for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinics of Arak city
Full name of responsible person
dr. Fardin Faraji
Street address
Arak University of Medical Sciences , Sardasht , Arak , Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences , Office of Vice Chancellor for Research
Full name of responsible person
Dr.Mohammad Rafii
Street address
Arak University of Medical Sciences , Sardasht , Arak , Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences , Office of Vice Chancellor for Research
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
Students Research Committe , Medicine faculty , Aarak University of Medical Sciences
Full name of responsible person
Shayan Amjadi
Position
M.D
Other areas of specialty/work
Street address
Arak University of Medical Science , Sardasht , Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
shayanamjadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neurology Department , Medicine faculty, Arak university of medical science
Full name of responsible person
Fardin Faraji
Position
Neurology specialist,Associate Professor
Other areas of specialty/work
Street address
Arak University Of Medical Science,Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
dr.faraji@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Students Research Committee , Arak University of Medical Sciences
Full name of responsible person
Shayan Amjadi
Position
M.D
Other areas of specialty/work
Street address
Aak University of Medical Science , Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)