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General information
2021-09-30, 1400/07/08
2021-12-28, 1400/10/07
2021-0912-3028 00:00:00
Protocol summary
Study aim
Determining the effect of saffron capsules on erectile dysfunction in men
Design
The present study is a clinical trial study with a control group and an intervention group that will be performed in parallel, without blinding, randomly on 24 men.
Settings and conduct
The study population: All men working at industrial towns of Larestan city
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years; Do not use alternative therapies such as hormone therapy; Having informed consent to participate in research; Ability to swallow and no oral and digestive problems; Candidates should not participate in other treatment programs that interfere with the present study. Non-inclusion criteria: Unwillingness of samples to participate in research;History of allergy to herbal medicines; Addiction to drugs, alcohol and painkillers; Consumption of psychiatric drugs; Having severe depression or anxiety
Intervention groups
Intervention group: daily intake of 2 capsules of 15 mg of saffron twice for 4 weeks.
Control group: No special treatment
Main outcome variables
The International Index of Erectile Function score
General information
Reason for update
Prolong the sampling process
Acronym
IRCT registration information
IRCT registration number:IRCT20090304001742N9
Registration date:2021-05-31, 1400/03/10
Registration timing:prospective
Last update:2023-03-11, 1401/12/20
Update count:2
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
mohammadrafi bazrafshan
Name of organization / entity
shiraz university medical science
Country
Iran (Islamic Republic of)
Phone
+98 917 382 1959
Email address
mrbazr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-01, 1400/03/11
Expected recruitment end date
2021-07-01, 1400/04/10
Actual recruitment start date
2021-06-01, 1400/03/11
Actual recruitment end date
2021-09-30, 1400/07/08
Trial completion date
2021-12-28, 1400/10/07
Scientific title
The effect of saffron on erectile dysfunction in men
Public title
The effect of saffron on erectile dysfunction in men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Do not use alternative therapies such as hormone therapy
Having informed consent to participate in research
Ability to swallow
No oral or digestive problems
Not participating in other treatment programs that interfere with the present study
Exclusion criteria:
History of allergy to herbal medicines
Addiction to drugs and alcohol and painkillers
Taking psychiatric drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
First, the list of industrial companies of Larestan city is written on paper, in the next step, the name of each center put in a separate envelope and one of the envelopes is selected at random. The researcher sampling men by referring to the selected industrial company using available sampling and applying the conditions for inclusion and non-inclusion the study. The samples allocated to intervention and control groups according to the block randomization. Thus, according to the sample size of this study, which is estimated to be 24 people, 4 blocks with 6 columns are used. Therefore, at the end, 12 people are placed in each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Larestan University of Medical Sciences
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City
City
Larestan
Province
Fars
Postal code
7431889629
Approval date
2021-03-01, 1399/12/11
Ethics committee reference number
IR.LARUMS.REC.1399.016
Health conditions studied
1
Description of health condition studied
Erectile dysfunction in men
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
The International Index of Erectile Function score
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
The International Index of Erectile Function
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention includes daily intake of 2 15-mg capsules of saffron twice a day for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: The control group does not receive any treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Larestan industrial companies
Full name of responsible person
Dr. Mohammad-Rafi Bazrafshan
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City
City
Larestan
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Fax
+98 71 5224 7111
Email
m.bazrafshan@larums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr Behzad Rezaei
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
دانشیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county
City
larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Behzad Rezaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county
City
larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' information can be shared after it becomes unrecognizable
When the data will become available and for how long
Access begins a year after the publication of results
To whom data/document is available
People who are working in the academic and scientific institutions
Under which criteria data/document could be used
It needs the agreement of Larestan University of Medical Sciences
From where data/document is obtainable
Dr. Mohammad Rafi Bazrafshan, Associate Professor, Larestan School of Medical Sciences, Email: m.bazrafshan@larums.ac.ir, Contact Phone: 07152247110, Mobile Number: 09173821959
What processes are involved for a request to access data/document
Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences