Protocol summary
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Study aim
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Determining the effect of saffron capsules on erectile dysfunction in men
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Design
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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.
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Settings and conduct
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The study population: All men working at industrial towns of Larestan city
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group: daily intake of 2 capsules of 15 mg of saffron twice for 4 weeks.
Control group: No special treatment
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Main outcome variables
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The International Index of Erectile Function score
General information
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Reason for update
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Prolong the sampling process
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Acronym
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IRCT registration information
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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
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Registration date
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2021-05-31, 1400/03/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-06-01, 1400/03/11
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Expected recruitment end date
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2021-07-01, 1400/04/10
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Actual recruitment start date
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2021-06-01, 1400/03/11
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Actual recruitment end date
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2021-09-30, 1400/07/08
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Trial completion date
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2021-12-28, 1400/10/07
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Scientific title
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The effect of saffron on erectile dysfunction in men
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Public title
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The effect of saffron on erectile dysfunction in men
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
24
Actual sample size reached:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-01, 1399/12/11
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Ethics committee reference number
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IR.LARUMS.REC.1399.016
Health conditions studied
1
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Description of health condition studied
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Erectile dysfunction in men
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ICD-10 code
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F52
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ICD-10 code description
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Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
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Description
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The International Index of Erectile Function score
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Timepoint
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Before the intervention and immediately after the intervention
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Method of measurement
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The International Index of Erectile Function
Intervention groups
1
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Description
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Intervention group: The intervention includes daily intake of 2 15-mg capsules of saffron twice a day for 4 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group does not receive any treatment.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Larestan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Participants' information can be shared after it becomes unrecognizable
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When the data will become available and for how long
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Access begins a year after the publication of results
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To whom data/document is available
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People who are working in the academic and scientific institutions
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Under which criteria data/document could be used
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It needs the agreement of Larestan University of Medical Sciences
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From where data/document is obtainable
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Dr. Mohammad Rafi Bazrafshan, Associate Professor, Larestan School of Medical Sciences, Email: m.bazrafshan@larums.ac.ir, Contact Phone: 07152247110, Mobile Number: 09173821959
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What processes are involved for a request to access data/document
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Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences
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Comments
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