The goal of research is the study of Gabapentine efficacy in the treatment of sleep distorbance and life quality of menopausal women. The method of study is randomized ,triple blind ,placebo controlled clinical trial .Study population menopausal women reffered to Thaleghani Hospital.Inclusion criteria :Passing at least 1 year after last menstural period ,absence of any physical or psychiatric disease ,dont using any drug and alcohale and smoking ,a score of at least 5 in Pittsburg sleep quality index ,informed written consent .
Exclusion criteria :Occuring of any physical or psychiatric disease during study which causes sleep disturbance ,noncompliance .
270 patients are randomly divided in 2 groups (intervention and control).Intervention group recieve gabapantin 300 mg twice daily for 12 weeks and controlled group recieve placebo for 12 weeks. Primary outcome ic change in the scores of Pittsburg sleep quality index and SF36 quality of life questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304184686N3
Registration date:2013-04-29, 1392/02/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-29, 1392/02/09
Registrant information
Name
Mehri Jamilian
Name of organization / entity
School of Medicine, Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
mjamilian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice president of education and research, Arak University of Medical sciences
Expected recruitment start date
2013-05-01, 1392/02/11
Expected recruitment end date
2013-09-01, 1392/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Gabapentin in the management of post menopausal sleep disorder and life quality
Public title
The efficacy of Gabapentin in the management of post menopausal sleep disorder and life quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: passing at least 1 year after last menstural period; absence of any physical or psychiatric disease; do not using any drug and alcohale and smoking; a score of at least 5 in Pittsburg sleep quality index; informed written consent.
Exclusion criteria: occuring of any physical or psychiatric disease during study which causes sleep disturbance and noncompliance.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
270
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
basij square
City
Arak
Postal code
3819691187
Approval date
2013-04-08, 1392/01/19
Ethics committee reference number
6-143-92
Health conditions studied
1
Description of health condition studied
Sleep disturbance
ICD-10 code
F51
ICD-10 code description
Nonorganic sleep disorders
Primary outcomes
1
Description
Pittsburg sleep quality index
Timepoint
before intervention and at the end of intervention
Method of measurement
clinical examination
2
Description
quality of life questionnaire SF36
Timepoint
before intervention and the end of intervention
Method of measurement
clinical examination
Secondary outcomes
1
Description
Somnolance and dizzines
Timepoint
Before intervention and at the end of intervention
Method of measurement
Clinical examination
Intervention groups
1
Description
Interventionl group recieve Gabapentin300 mg twice daily for 12 weeks
Category
Treatment - Drugs
2
Description
Control group recieve placebo twice daily for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mehri Jamilian
Street address
Taleghani Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University Medical of Sciences
Full name of responsible person
Dr.Ashtiany
Street address
Basij square
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 Medical of 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
Arak University of Medical Sciences
Full name of responsible person
Mehri jamilian
Position
Board of Obstetric and Gynecology,Assistant professor
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
Phone
+98 86 1278 0660
Fax
Email
MJAMILIAN@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak Unicesversity of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric
Other areas of specialty/work
Street address
Basij square
City
Arak
Postal code
Phone
+98 86 1278 0660
Fax
Email
mjamilian@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Assistant professor .Board of Obstetric
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
Phone
+98 86 1278 0660
Fax
Email
mjamilian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)