Our objective is to assess efficacy of Cap. saffron in the treament of sexual dysfunction induced by Selective Seretonin Reuptake Inhibitors. Forthy patients with diagnosis of major depression who have already received Selective Seretonin Reuptake Inhibitors for 4 weeks will be entered into a 4-week double blind randomised trial. One group will receive Cap Saffron (30 mg/day) and another group will receive Cap Placebo. They will be assessed by international index of Erectile Function every two weeks for one month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711121556N3
Registration date:2009-02-11, 1387/11/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2009-02-11, 1387/11/23
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-02-20, 1387/12/02
Expected recruitment end date
2010-02-20, 1388/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Crocus Sativus L. on sexual dysfunction induced by Selective Seretonin Reuptake Inhibitors in male: a clinical trial
Public title
Saffron and decrease of sexual dysfunction induced by fluoxetin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: at least 4 weeks usage of fluoxetin before study, do not use any psychotherapeutics except Selective Seretonin Reuptake Inhibitors, lack of chronic and organic disorders including cardiovascular diseases, informed consent. Exclusion Criteria: substance dependence, organic disorders, other psychiatric comorbidity including biploar disorder, use of psychotropic drugs.
Age
From 20 years old to 45 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv.
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
8145
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Lack or loss of sexual desire
Primary outcomes
1
Description
Score of international index of Erectile Function
Timepoint
every two weeks
Method of measurement
use of international index of Erectile Function
Secondary outcomes
empty
Intervention groups
1
Description
Cap Saffron 15 mg twice per day as intervention group
Category
empty
2
Description
Cap Placebo twice per day as control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Psychiatric Hospital
Full name of responsible person
Dr. Firoozeh Raisi
Street address
Roozbeh Psychiatric Hospital, South Kargar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Ph.D., Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Psychiatric Hospital
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21555419113
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of Medical sciences
Full name of responsible person
Prof. shahin akhondzadeh
Position
Ph.D., Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Psychiatric Hospital
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)