The aim of this study is to compare the effect of lavandula and citrus aurantium on depression and sleep quality in menopausal women.This study is a randomized clinical trial, triple- blind, controle with placebo. The samples are postmenopausal women aged 45 to 60.The sample size is 156 women and the intervention period is 8-weeks. These women randomly were allocated into 3 groups (citrus aurantium, lavender and placebo) based on3 and 6 blocks randomization method. The same capsules Contains of 500 mg citrus aurantiumand lavender flower’s Powder and placebo( starch) prepared by Yashil drug Sahand Pharmacotical Company. For allocation concealment, drugs and placebo were placed in the same closed opaque envelopes that serial numbered according to allocation sequence. Block scheduling and preparing envelopes were performed by a person not involved in the sampling and data analysis. They will enter to study by the order number on the envelope. For reminding, 2 and 6 weeks after the start of the study phone call with participants will be taken by the researcher.Sleep quality and depression in all three groups before and after intervention will be measured by Pittsburgh and Beck questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504236582N11
Registration date:2015-10-09, 1394/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-09, 1394/07/17
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lavandula and citrus aurantium on depression and sleep quality in menopausal women
Public title
Comparison of the effect of lavandula and citrus aurantium on depression and sleep quality in menopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria: 45-60 years old; 1 to 6 years after the last menstrual period which start by natural menopause; getting more than 5 score from Pittsburgh Sleep Quality Index (PSQI);getting between4-28 score from Beck depression score; not taking hypnotic and anti depressant drugs; not taking tobacco and alcohol; having phone number for follow-up; without history of asthma and allergy to specific plants or citrus; Lack of acute gastrointestinal problems declared by herself; Living in Urmia; the desire to participate in the study
Exclusion Criteria: Having travel or home change during intervention; Having a history of severe physical and mental disease that causes sleep disorders and depression; Death of a relative in the past three months, encounter with the events that caused sleep disorders and depression; Regular weekly or professional exercise; The use of other methods of traditional medicine
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
156
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences Research Administration
City
Tabriz
Postal code
Approval date
2015-05-11, 1394/02/21
Ethics committee reference number
TBZMED.REC.1394.98
Health conditions studied
1
Description of health condition studied
sleep quality
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
2
Description of health condition studied
depression
ICD-10 code
F32.0
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
sleep quality
Timepoint
before and 8 week after intervention
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
depression
Timepoint
before and 8 week after intervention
Method of measurement
Beck Depression Questionnaire
Secondary outcomes
1
Description
Satisfaction of postmenopausal women
Timepoint
8 weeks after intervention
Method of measurement
Checklist
2
Description
Anxiety
Timepoint
Before and 8 weeks after intervention
Method of measurement
(STAI) questionnaire
3
Description
Adverse events
Timepoint
8 weeks after intervention
Method of measurement
Checklist
4
Description
Personal and social characteristics associated with depression and sleep quality scores in the groups studied
Timepoint
Before intervention
Method of measurement
Demographic questionnaire
Intervention groups
1
Description
The citrus aurantium group will receive capsules containing 500 mg Citrus aurantium flower’s Powder twice a day after breakfast and dinner for 8 weeks.
Category
Treatment - Drugs
2
Description
The lavender group will receive capsules containing 500 mg of Lavender flower’s Powdertwice a day after breakfast and dinner for 8 weeks.
Category
Treatment - Drugs
3
Description
The control group will receive capsules containing 500 mg starchtwice a day after breakfast and dinner for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mahsa Namadian
Street address
City
Urmia
2
Recruitment center
Name of recruitment center
Fatemie Hospital
Full name of responsible person
Mahsa Namadian
Street address
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Street address
Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Master Sciences of Midwifery
Other areas of specialty/work
Street address
Shariaty st, Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Postal code
5138947977
Phone
+98 34796770
Fax
Email
kamalifardm@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Master Sciences of Midwifery
Other areas of specialty/work
Street address
Shariaty st, Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 914 314 6763
Fax
Email
kamalifardm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Master Sciences of Midwifery
Other areas of specialty/work
Street address
Shariaty st, Nursing and Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
Fax
Email
kamalifardm@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)