Due to the increasing population of postmenopausal women and high prevalence of sleep disorders in these people, beside the general trend in the use of herbal medicines, careful consideration in order to achieve low risk and also more effective treatment for sleep disorders is essential.
This study is a triple-blind clinical trial (samples, the distributor of the drug and the person who will do analysis of data will not be aware of drugs) in which subjects according to inclusion criteria selected by Convenient sampling , and randomly placed in one of group.
Study will be done on 110 postmenopausal 50-60 years old women. Intended intervention is consumption of lemon balm capsules(capsules containing 250 mg extract of lemon balm twice a day) in one of group and consumption of Chamomile capsules(capsules containing 400 mg extract of Chamomile twice a day) in other group for a month.
Instruments of this study are demographic questionnaire and Pittsburgh Sleep Quality Index that before and one month after starting taking medication in order to evaluate the symptoms of sleep disorders will be completed by the symptoms and finally data will be analyzed using of statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015073110076N5
Registration date:2015-09-04, 1394/06/13
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-09-04, 1394/06/13
Registrant information
Name
Maryam Saeedi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3524
Email address
m.saeedi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Arak University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of lemon Blam and chamomile on sleep disorders in menopausal women
Public title
Comparison of Lemon Blam and chamomile effect on sleep disorders in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Passing at least a year since the last menstrual period after the onset of natural menopause, having mild and moderate sleep disturbances on Pittsburgh Sleep Quality index, Lack of physical and mental illness affecting sleep (asthma, thyroid disorders, etc) ,Do not use of medications that affect sleep quality (diuretics, etc.), tobacco and alcohol, Not having sensitivity to food, medicines or certain substances
Exclusion criteria: Development of physical and mental illness During the study period, emergence of unpredictable and significant change in sleep conditions as travel, move,etc. Use of any additional drug during the study , Not taking medications for up to 7 days in a month, Not having sensitivity to food, medicines or certain substances
Age
From 50 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University Of Medical Sciences
Street address
Vice Chancellor for research of Arak University of Medical Sciences, Arak
City
Arak
Postal code
Approval date
2015-06-29, 1394/04/08
Ethics committee reference number
IR.ARAKMU.REC.1394.78
Health conditions studied
1
Description of health condition studied
Seep disorder
ICD-10 code
G47
ICD-10 code description
Other sleep disorders
Primary outcomes
1
Description
sleep disorder
Timepoint
after study and one month after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
" Intervention group1": Consumption of lemon balm capsules(capsules Containing 250 mg extract of lemon balm twice a day) in one of group for one month
Category
Treatment - Drugs
2
Description
"Intervention group 2": Consumption of Chamomile capsules(capsules containing 400 mg extract of Chamomile twice a day) in other group for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics in Arak affiliated to Arak university of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Street address
Arak
City
arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr Ghazavi
Street address
Department Of research&Technology, Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Arak 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
Arak University Of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
MSC in Nursing
Other areas of specialty/work
Street address
Nursing&Midwifery Faculty, Sardasht, Arak
City
Arak
Postal code
Phone
+86 34173503
Fax
Email
zeinab_alizadeh88@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
MSc in Nursing
Other areas of specialty/work
Street address
Nursing&Midwifery faculty, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
zeinab_alizadeh88@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
MSc in Nursing
Other areas of specialty/work
Street address
Nursing&Midwifery Faculty, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)