The plan consists of two parts. In the first part, Pre-menopausal and menopausal women diagnosed by gynecologist and filled the demographic questionnaire and Subjective Sleep Quality Inventory (PSQI) and if the total score is more than 5,they are selected as patients with sleep disorder. Then patients were randomly divided into three 30 person group which divided into case and control group. Randomly, for 6 weeks at night, one group treated with melatonin (3 mg), another group treated with Zolpidem (10 mg) and another group set as placebo group. Before trial and end of period (6 weeks) Subjective Sleep Quality Inventory (PSQI) will be filled for patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010216035N1
Registration date:2014-02-23, 1392/12/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-23, 1392/12/04
Registrant information
Name
somayeh shokrgozar
Name of organization / entity
guilan university of madical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 6628
Email address
dr_shokrgozar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan university of medical science
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of melatonin and zolpidem compared with placebo on sleep disorders in premenopause and menopause women
Public title
Effects of melatonin and zolpidem compared with placebo on sleep disorders in premenopause and menopause women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of Pre- menopause and menopause to be confirmed; the absence of chronic medical conditions that can lead to sleep disorders. Exclusion criteria: Failure to diagnosis the menopause and premenopause; use of psychiatric drugs such as anti-psychotics and hypnotics and mood stabilizer drugs; chronic medical conditions leading to sleep disorders (diabetes, cardiovascular diseases, obesity ); autoimmune Diseases; contraindication of taking melatonin (receiving medication of immunosuppressive drugs, sensitivity to melatonin, high blood pressure, liver dysfunction, history of seizures ); sensitivity to Zolpidm; receiving HRT ( hormone replacement therapy ); sleep disorder caused by taking certain psychiatric disorders ( major depression , bipolar, anxiety, dementia); disasters and adverse event
Age
From 50 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Guilan university of medical sciences
Street address
Shafa educational and remedial center, 15 khordad street
City
Resht
Postal code
4193955599
Approval date
2013-12-07, 1392/09/16
Ethics committee reference number
1920341302
Health conditions studied
1
Description of health condition studied
Sleep disorder due to premenopause and menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Sleep Quality
Timepoint
6 weeks
Method of measurement
Subjective Sleep Quality Questionnaire(PSQI)
Secondary outcomes
1
Description
Quality of life
Timepoint
6 weeks
Method of measurement
SF-36 Quality of Life Questionnaire
Intervention groups
1
Description
Thirteen participants will be in 2 groups, including two tests and a control groups randomly during in 6 weeks at night, a group treated with melatonin (3 mg) and a group treated with Zolpidem (10 mg)
Category
Treatment - Drugs
2
Description
Thirteen participants in control group treated with placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital women's clinic
Full name of responsible person
Dr Somayeh Shokrgozar,Professor assistance 0f psychiatry
Street address
Azzahra hospital, Namjoo street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr somayeh shokrgozar
Street address
Shafa educational and remedial center ,15 khordad avenue.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan university of medical sciences
Full name of responsible person
Dr somayeh shokrgozar
Position
Psychiatrist
Other areas of specialty/work
Street address
Shafa educational and remedial center ,15 khordad street
City
Rasht
Postal code
4193955599
Phone
+98 13166
Fax
+98 13 1666 6268
Email
DR.shokrgozar@yahoo.com/Dr_shokrgozar@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr Somayeh Shokrgozar
Position
Psychiatrist
Other areas of specialty/work
Street address
Shafa educational and remedial center ,15 khordad street
City
Rasht
Postal code
4193955599
Phone
+98 13 1666 6268
Fax
+98 13 1666 6268
Email
DR.shokrgozar@yahoo.com/Dr_shokrgozar@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr somayeh shokrgozar
Position
Psychiatrist
Other areas of specialty/work
Street address
Shafa educational and remedial center ,15 khordad street
City
Rasht
Postal code
4193955599
Phone
+98 13 1666 6268
Fax
+98 13 1666 6268
Email
DR.shokrgozar@yahoo.com/Dr_shokrgozar@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)