The efficacy of use and without use of Rosa damascenes extract in treatment of sexual dysfunction induced by Selective Serotonin Reuptale Inhibitors in women with Major Depressive Disorder
The purpose of this study was to evaluate the efficacy of Rosa damascenes extracts in the treatment of sexual dysfunction induced by serotonin reup take inhibitors in women with major depressive disorders.This is a triple-blind clinical trial.50 married women referred to Kermanshah Farabi Hospital were selected and randomly divided in to two equal intervention and control groups.The intervention group received 3cc Rosa damascenes drop daily for 8 weeks which was equivalent to17mg citronellol.The control group received 3cc distilled water (placebo)daily.Then at the beginning of the study, four and eight week of the study, libido,sexual arousallevels, orgasmic disorders, sexual pain disorders and sexual satisfaction were examined.Inclusion criteria: Patients with major depressive disorder saccording to DSM IV; and those who had been treated with a fixed dose of serotonin reup take in hibitors for at least eight weeks.
Exclusion criteria: presence of sexual dysfunction before taking serotonin reup take inhibitors; presence of any systemic or psychiatric disorders, Thyroid disease and hyperprolactinemia or taking any medication which affects sexual activity; any history of drug or alcohol use during 6 recent months; those who have recently had significant changes in sexual activity due to pregnancy,remarriage and divorce.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100114333N9
Registration date:2013-10-18, 1392/07/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-10-18, 1392/07/26
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of use and without use of Rosa damascenes extract in treatment of sexual dysfunction induced by Selective Serotonin Reuptale Inhibitors in women with Major Depressive Disorder
Public title
The efficacy of Rosa damascenes extract in treatment of sexual dysfunction induced by Selective Serotonin Reuptale Inhibitors in women with Major Depressive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with major depressive disorders according toDSM IV; those who had been treated with a fixed dose of serotonin reup take in hibitors for at least eight weeks.
Exclusion criteria: presence of sexual dysfunction before taking serotonin reup take inhibitors; presence of anysystemic or psychiatric disorders , Thyroid disease and hyperprolactinemia or taking any medication which affects sexual activity; anyhistory of drug or alcohol use during 6 recent months; those who have recently had significant changes in sexual activity due to pregnancy, remarriage and divorce
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-06-25, 1392/04/04
Ethics committee reference number
12495/پ/7/420
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
libido
Timepoint
At the beginning, 4th and 8th week of the study
Method of measurement
Asking the patient
2
Description
Levels of sexual arousal
Timepoint
At the beginning, 4th and 8th week of the study
Method of measurement
Asking the patient
3
Description
Orgasmic disorders
Timepoint
At the beginning, 4th and 8th week of the study
Method of measurement
Asking the patient
4
Description
Sexual pain disorders
Timepoint
At the beginning, 4th and 8th week of the study
Method of measurement
Asking the patient
5
Description
Sexual Satisfaction
Timepoint
At the beginning, 4th and 8th week of the study
Method of measurement
Asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received 3cc Rosa damascenes dropdaily for 8 weeks which was equivalent to17mg citronellol
Category
Treatment - Drugs
2
Description
The control group received 3cc distilled water (placebo) daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Dr. Sara hojatitabar
Street address
First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Psychiatrist
Other areas of specialty/work
Street address
First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 1826 0700
Fax
Email
vfarnia@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)