Protocol summary
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Study aim
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Comparison of lemon Balm and chamomile on sleep disorders of menopausal women
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Design
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This study is a triple-blind clinical trial.subjects will be selected by convenience sampling method then they will be randomly assigned to one of the groups. study will be conducted on 110 postmenopausal 50-60 years old women. intervention includes taking lemon balm capsule in one group and chamomile capsule in other group for one month. one month after starting medication, Pittsburgh Sleep Quality Index will be completed by subjects and finally, data will be analyzed using statistical tests.
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Settings and conduct
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The study will be conducted on 110 postmenopausal 50-60 years old women referred to Arak health centers. intervention includes taking lemon balm capsule(250 mg extract of lemon balm) in one group and chamomile capsule(400 mg extract of Chamomile) in other group for one month
and twice a day.
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Participants/Inclusion and exclusion criteria
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Mild and moderate sleep disorder based on Pittsburgh Sleep Quality Questionnaire,lack of physical and mental illness affecting sleep,not taking drugs that affect sleep quality.
Unpredictably significant change in sleep conditions Including travelling
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Intervention groups
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Consumption of lemon balm in group 1 and chamomile in group 2
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Main outcome variables
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sleep hygiene
General information
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Reason for update
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To correct title spelling mistake
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015073110076N5
Registration date:
2015-09-04, 1394/06/13
Registration timing:
registered_while_recruiting
Last update:
2019-11-05, 1398/08/14
Update count:
1
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Registration date
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2015-09-04, 1394/06/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for research of Arak University of Medical Sciences
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Expected recruitment start date
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2015-08-23, 1394/06/01
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Expected recruitment end date
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2015-12-22, 1394/10/01
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Actual recruitment start date
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2015-08-23, 1394/06/01
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Actual recruitment end date
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2015-12-22, 1394/10/01
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Trial completion date
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2015-12-22, 1394/10/01
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Scientific title
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Comparison of effectiveness of lemon Balm and chamomile on sleep disorders in menopausal women
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Public title
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Comparison of Lemon Balm and chamomile effect on sleep disorders in menopausal women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
menopause women
Mild and moderate sleep disorder based on Pittsburgh Sleep Quality Questionnaire
lack of physical and mental illness affecting sleep
not taking drugs that affect sleep quality
Exclusion criteria:
Unpredictably significant change in sleep conditions Including travelling, relocation
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Age
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From 50 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
110
Actual sample size reached:
108
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples were selected by convenience sampling and were randomly divided into intervention and control groups using random number table.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Subjects, researcher and data analyser were blinded
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-06-29, 1394/04/08
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Ethics committee reference number
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IR.ARAKMU.REC.1394.78
Health conditions studied
1
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Description of health condition studied
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Seep disorder
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ICD-10 code
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G47
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ICD-10 code description
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Other sleep disorders
Primary outcomes
1
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Description
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sleep disorder
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Timepoint
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after study and one month after intervention
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Method of measurement
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Pittsburgh Sleep Quality Index
Intervention groups
1
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Description
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" 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
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Category
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Treatment - Drugs
2
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Description
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"Intervention group 2": Consumption of Chamomile capsules(capsules containing 400 mg extract of Chamomile twice a day) in other group for one month
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for research of Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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When the data will become available and for how long
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To whom data/document is available
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Under which criteria data/document could be used
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From where data/document is obtainable
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What processes are involved for a request to access data/document
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Comments
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