Comparison of the effect of date pollen and placebo on improving of sexual function in sexually active women 25-45 years old: a double blind clinical trial
The effect of Date pollen pills to improve female sexual function
Design
The present study is a double-blind clinical trial on 50 sexually active women 25-45 years. The data collection method will be convenience sampling, then the blocking method will be used for random allocation of the intervention and control groups. In this way, 6 status of the 4-block were inserted into the paper sheets, then the papers were randomly removed (with replacement)and the random arranged was determined until the desired sample size was reached
Settings and conduct
All women ages 25 to 45 years old who use IUD for contraceptive refer to Health Care Centers (No. 1,2 and 3) in Khalkhal City.Samples and clinical caregivers will be blind.
Participants/Inclusion and exclusion criteria
Giving Informed consent, having a husband, having an IUD at least six months in advance, ages25-45 years, Not having abortions in the past six months, Having no infant, Not having cognitive and systemic psychological disorders affecting sexual function, having at least reading literacy and writing, not using drugs that affect sexual function, insensitivity to herbs and pollen, no smoking, alcohol or drugs
Intervention groups
Intervention group: Daily use of tablets containing 300 mg of palm pollen for 35 days
Control group:Daily use of placebo for 35 days
Main outcome variables
Sexual Function Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190622043970N1
Registration date:2020-01-02, 1398/10/12
Registration timing:registered_while_recruiting
Last update:2020-01-02, 1398/10/12
Update count:0
Registration date
2020-01-02, 1398/10/12
Registrant information
Name
roghayeh salmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3243 3017
Email address
r.salmani@khalums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of date pollen and placebo on improving of sexual function in sexually active women 25-45 years old: a double blind clinical trial
Public title
The effect of date pollen on sexual function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent,Having a husband
having an IUD at least six months in advance
ages 25-45 years
Not having abortions in the past six months
Having no infant
Not having cognitive and systemic psychological disorders affecting sexual function
having at least reading literacy and writing
not using drugs that affect sexual function
insensitivity to herbs and pollen
no smoking, alcohol or drugs
Exclusion criteria:
Unwillingness to continue research
being away from husband for various reasons and having another spouse
having depression
breast feeding
abortion or children death during the past six months
pregnancy
allergy to dates
Age
From 25 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The data collection method will be convenience sampling, then the blocking method will be used for random allocation of the intervention and control groups. 6 status of the blocks with the size of 4 were written into the paper sheets, then the papers were randomly picked (with replacement) and the chain of randomization was built until the desired sample size was reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study samples and clinical caregivers are not aware of the drug or pharmacopoeia of the pills received
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Khalhkal University of Medical Sciences
Street address
Kashif1, Shahid Bakri Ave
City
Khalkhal
Province
Ardabil
Postal code
5681933491
Approval date
2019-09-04, 1398/06/13
Ethics committee reference number
IR.KHALUMS.REC.1398.001
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
F52.0
ICD-10 code description
Lack or loss of sexual desire
Primary outcomes
1
Description
Sexual function
Timepoint
Before and 35 days after intervention
Method of measurement
Female Sexual Function Index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the subjects will consume 35 tablets containing 300 mg of palm pollen daily.
Category
Treatment - Drugs
2
Description
Control group: In this group, the subjects will consume 35 placebo tablets daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalkhal Health Centers
Full name of responsible person
Roghayeh Salmani
Street address
Kashif 1, Shahid Bakri Street
City
Khalkhal
Province
Ardabil
Postal code
5681933491
Phone
+98 45 2423 3017
Email
R.Salmani@Khalums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Khalkhal School of Medical Sciences
Full name of responsible person
Dr Bagher Hayati
Street address
The Khalkhal School of Medical Sciences. Shahid Mozafar Azizi Ave.
City
Khalkhal
Province
Ardabil
Postal code
5681854357
Phone
+98 45 3242 2002
Email
Bagher.hayati90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Khalkhal School 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
The Khalkhal School of Medical Sciences
Full name of responsible person
Roghayeh Salmani
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kashf1,Shahid bakeri Ave
City
khalkhal
Province
Ardabil
Postal code
5881854357
Phone
+98 45 3243 3017
Email
R.salmani@khalums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Khalkhal School of Medical Sciences
Full name of responsible person
Roghayeh Salmani
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kashif1, Shahid Bakeri Ave
City
Khalkhal
Province
Ardabil
Postal code
5881854357
Phone
+98 45 2423 3017
Email
R.Salmani@khalums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khalkhal School of Medical Sciences
Full name of responsible person
Roghayeh Salmani
Position
faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
kashif1, shahid Bakeri Ave
City
khalkhal
Province
Ardabil
Postal code
5881854357
Phone
+98 45 2423 3017
Email
R.salmani@khalums.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
Yes - There is 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
Questionnaire and spss file
When the data will become available and for how long
Starting data access period, one year after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to the results of the analysis
From where data/document is obtainable
R.Salmani@khalums.ac.ir
Salmany.Ro@gmail.com
What processes are involved for a request to access data/document
Data request or file, follow up one week after request