Protocol summary

Summary
The purpose of this study is to evaluate the efficacy of Rosa damascenes extracts in the treatment of sexual dysfunction induced by serotonin reuptake inhibitors in men with major depressive disorders. This is a triple-blind clinical trial.60 married men referred to Kermanshah Farabi Hospital were selected and randomly divided into two groups. The intervention group received 3 cc Rosa damascenes drop daily for 8 weeks which was equivalent to 17 mg citronellol. The control group received 3 cc distilled water (placebo) daily. Then at the beginning of the study, fourth and eighth week of the study, libido and sexual level, erection times, hardness and stiff of erection, hardness of flow out of semen, the problem of amount and flow out of semen, lack of libido, the problem of become erect and keeping it, and sexual satisfaction were examined. Inclusion criteria: Patients with major depressive disorders; and those who had been treated with a fixed dose of serotonin reuptake inhibitors for at least eight weeks; those who haven’t sexual disorder before begin the treatment and they affected sexual disorder with use of this medicines Exclusion criteria: presence of sexual dysfunction before taking serotonin reuptake 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 their wife pregnancy, remarriage and divorce.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013100814333N10
Registration date: 2013-10-22, 1392/07/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-10-22, 1392/07/30
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 damascene extract in treatment of sexual dysfunction induced by Selective Serotonin Reuptale Inhibitors in men with Major Depressive Disorder
Public title
The efficacy of Rosa damascene extract in treatment of sexual dysfunction induced by Selective Serotonin Reuptale Inhibitors in men with Major Depressive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with major depressive disorders according to DSM IV; and those who had been treated with a fixed dose of serotonin reuptake inhibitors for at least eight weeks; those who haven’t sexual disorder before begin the treatment and they affected sexual disorder with use of this medicines such as decrease of libido, erection disorder ,delay of orgasm or dis ability to become orgasm Exclusion criteria: presence of sexual dysfunction before taking serotonin reuptake 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 their wife pregnancy, remarriage and divorce
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
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
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
2010-09-23, 1389/07/01
Ethics committee reference number
11884/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
Days libido
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

2

Description
libido
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

3

Description
Erection times
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

4

Description
Erection stiff
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

5

Description
Erection hardness
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

6

Description
Hardness of flow out of semen
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

7

Description
The problem of semen Amount
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

8

Description
The problem of lack of semen
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

9

Description
Sexual Satisfaction
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

10

Description
The problem of ability to become erect and keeping it
Timepoint
At the beginning, 4th and 8th the week of study
Method of measurement
Asking the patient

11

Description
Serotonin reuptake inhibitors
Timepoint
At the beginning, 4th and 8th the study week of
Method of measurement
Asking the patient

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group received 3 cc Rosa damascenes drop daily for 8 weeks which was equivalent to 17 mg 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. Mehdi Shirzadifar
Street address
first of Dolatabad Boulvard,Eisar Squqre
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 Squqre
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)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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