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The effect of Crocus sativus on sexual dysfunction in male referred to Rouzbeh and Imamkhomeini Hospital : a clinical trial

Protocol summary

Study aim
The aim of this study is to assess the efficacy of saffron in the treatment of male erectile disorder
Design
Randomized double blind placebo-controlled clinical trial
Settings and conduct
The study will be conducted among the men with erectile disorder attending Roozbeh Hospital and Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: men with erectile disorder; married Exclusion criteria: Endocrine disease;Diabetes mellitus; metabolic syndrome; severe depression
Intervention groups
Intervention group: saffron 15 mg BID for 6 weeks
Main outcome variables
Severity of erectile disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090117001556N109
Registration date: 2018-07-24, 1397/05/02
Registration timing: prospective

Last update: 2018-07-24, 1397/05/02
Update count: 0
Registration date
2018-07-24, 1397/05/02
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
Expected recruitment start date
2018-08-05, 1397/05/14
Expected recruitment end date
2020-08-04, 1399/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Crocus sativus on sexual dysfunction in male referred to Rouzbeh and Imamkhomeini Hospital : a clinical trial
Public title
The effect of Crocus sativus on sexual dysfunction in male
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married men Erectile disorder Age between 18 to 45 years Score 25 or less on IIEF (International Index of Erectile Function)
Exclusion criteria:
Endocrine disease Severe depression Metabolic syndrome Diabetes Mellitus Coagulopathy Receiving warfarin Hypertension
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Computerized randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, evalvators and clinicians will be blind to grouping
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
IR.TUMS.VCR.REC.1397.222

Health conditions studied

1

Description of health condition studied
En Male Erectile Disorder
ICD-10 code
F52.21
ICD-10 code description
Male erectile disorder

Primary outcomes

1

Description
En severity of erectile disorder
Timepoint
Baseline and weeks 3 and 6
Method of measurement
By IIEF(International Index of Erectile Function)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Crocus sativus 15 mg BID for 6 weeks
Category
Treatment - Drugs

2

Description
Control group: Placebo for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital-Tehran
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
Imam Khomeini hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1571
Fax
+98 21 6658 1615
Email
Imamhospital@tums.ac.ir

2

Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Keshvarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
Msahrai@tums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data will be distributed through final report
When the data will become available and for how long
5 years-2020 to 2025
To whom data/document is available
All academic researchers
Under which criteria data/document could be used
all users should cite the resours of data
From where data/document is obtainable
prof Shahin Akhondzadeh
What processes are involved for a request to access data/document
by E mail
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