The aim of this study is to Compare the effect of Echium amoenum extract with fluoxetine on depression in menopausal women. This study is double-blind clinical trial that will be conducted on 72 menopausal women with moderate to severe depression referring to No. 7 and No. 1 health center of Ahvaz University of Medical sciences in 2017. The inclusion criteria require that the menopausal women have amenorrhea for at least 12 months; the participants age be between 45 and 60 years and Major depression criteria based on DSM-5, According to psychiatrist visit; patients with moderate to severe depression (14-22 with a test of Hamilton depression score). The exclusion criteria include: patients with depression that have suicidal thoughts; very severe depression; Sensitivity to the fluoxetine; Getting any systemic disease such as (high blood pressure; diabetes; renal disease); Taking antidepressant medication; alcohol consumption; Use of herbal medicines for treatment of menopausal symptoms; use of Drugs that interfere with fluoxetine; surgery such as hysterectomy, Vaginoplasty. The experimental group (n=36) will receive a 500mg Echium amoenum extract capsule while the control group (n=36) will be taking a 20 mg fluoxetine capsule daily for 8 weeks of intervention . The severity of depression will be measured before the intervention and in the, fourth,,sixth and eighth weeks after intervention.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017051133925N1
Registration date:2017-07-18, 1396/04/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-18, 1396/04/27
Registrant information
Name
parisa yousefee baghbadorany
Name of organization / entity
Ahvaz JundiShapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 3202
Email address
yousefee.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Echium amoenum extract with fluoxetine on depression in menopausal women.
Public title
Comparison the effect of Echium amoenum extract with fluoxetine on depression in menopausal women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria require that the menopausal women have amenorrhea for at least 12 months; the participants age be between 45 and 60 years and Major depression criteria based on DSM-5, According to psychiatrist verdict; patients with moderate to severe depression (14-22 with a test of Hamilton depression score). The exclusion criteria include: patients with depression that have suicidal thoughts; severe depression; Sensitivity to the fluoxetine; Getting any systemic disease such as( high blood pressure;diabetes; renal disease); Taking antidepressant medication; alcohol consumption; Use of herbal medicines for treatment of menopausal symptoms; use of Drugs that interfere with fluoxetine; surgery such as hysterectomy radical women, Vaginoplasty and artificial menopause.
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:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Ahvaz JundiShapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Science and Health Services, Golestan BLV, Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.AJUMS.REC.1396.325
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F33.1 , F3
ICD-10 code description
Recurrent depressive disorder, current episode moderate.Recurrent depressive disorder, current episode severe without psychotic symptoms
Primary outcomes
1
Description
Depression levels
Timepoint
0 week, 4 week, 6 week, 8 week
Method of measurement
phycologist and Hamilton questioner
Secondary outcomes
1
Description
Diarrhea
Timepoint
Daily
Method of measurement
Self report
Intervention groups
1
Description
In the intervention group 500 mg Echium amoenum extract (capsule) will be administered daily for 8 week .
Category
Treatment - Drugs
2
Description
In The control group 20 mg fluoxetine (capsule) will be administered daily for 8 weeks .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center number 7 to Ahvaz
Full name of responsible person
parisa yousefee baghbadorani,Student Of Ms Degree Midwifery . Jondishapoor University of Medical Sci
Street address
Health Center number 7,Road Mallashiyeh,khorramshahr highway
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Doctor Behzad Sharif Makhmalzadeh
Street address
Ground floor, Ahvaz Junishapur University of Medical Science and Health Services of Department Research Development and Technological, Academic city, Ahvaz
City
Ahvaz
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, Ahvaz Jundishapur University of Medical Science
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
ahvaz medical university
Full name of responsible person
mitra tadayon najafabady
Position
post graguate
Other areas of specialty/work
Street address
ahvaz medical university
City
ahvaz
Postal code
6135715794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
mitratadayon2000@yahoo.com
Web page address
www.fnursing.ajums.ac.ir, www.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
mitra tadayon najafabady
Position
post graguate
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Science and Health Services, Golestan BLV, Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
mitratadayon2000@yahoo.com
Web page address
fnursing-ahvaz@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
JundiShapur University of Medical Sciences and Health Services, School of Nursing and Midwifery
Full name of responsible person
Parisa yousefee baghbadorani
Position
Student Masters of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, JundiShapur University of Medical Sciences, Golestan BlV, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61333738331
Fax
+98 61 3373 8333
Email
yousefee.p@ajums.ac.ir, parisayy@gmail.com
Web page address
www.fnursing.ac.ir, www.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)