Evaluating the effects of Iranian traditional medicine diets on erectile function and semen analysis of men
Design
A controlled clinical trial, with parallel groups, not blinded, randomised, phase 2 on 159 patient.That use Excel application for randomization.
Settings and conduct
Sampling will be performed on all oligospermia patients referred to the infertility clinic of clinics affiliated to Shiraz University of Medical Sciences who have consciously participated in the project after expressing the call and giving the necessary explanations.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adults men with age of 18-45 years old,Oligospermia with BMI 18.5-30 , Satisfaction form
؛Exclusion criteria: Anatomical infertility findings, Heart and vessels diseases, Prostate cancer, Diabetes mellitus, Hypertension
Intervention groups
First group wil recive Persian medicine regim advices
Second group will receive Mediterranean regim advices
Evaluating the effects of Iranian traditional medicine diets on erectile function and semen analysis of men
Public title
Evaluating the effects of Iranian traditional medicine diets on erectile function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Oligospermia
Iranian nation
Age 18-45
Consensus
Adults men
BMI 18.5-30
Exclusion criteria:
Anatomical infertility findings
Prostate cancer
Heart disease
Hypertension
Diabetes mellitus
Herbal remedies use
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Randomisation by lottery; Researchers and volunteers can't predict the type of intervention in this study.We use the Hat App for this method.Such, numbers of all volunteers send to the Hat App.This app do lottery and a number will separate .Outcome of first lottery will entrance to Control group. Outcome of second lottery will entrance to the group that recive Iranian traditional medicine diet and outcome of third lottery will entrance to group that recive Mediterranean diet and then this method will continue till 159 volunteers do the lottery.
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 Shiraz University of Medical Sciences
Street address
South Iman blvd, Sheikhi avenue
City
Shiraz
Province
Fars
Postal code
7185999349
Approval date
2021-05-12, 1400/02/22
Ethics committee reference number
IR.SUMS.MED.REC.1400.100
Health conditions studied
1
Description of health condition studied
Erectile dysfunction
ICD-10 code
N52
ICD-10 code description
Male erectile dysfunction
2
Description of health condition studied
Oligospermia
ICD-10 code
N46.1
ICD-10 code description
Oligospermia
Primary outcomes
1
Description
Semen parameters
Timepoint
Semen analysis in the beginning of the research,finshed the first and second month after the use of diet advice
Method of measurement
Semen analysis
2
Description
Erectile function
Timepoint
Erectile function changing in the beginning of the research,finshed the first and second month after the use of diet advice
Method of measurement
The international index of erectile function (IIEF)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group:(first day) patients must fill the Iranian traditional medicine questionnaire. Rate of interest and fallowing of the Iranian traditional medicine diet will register by scoring system of this questionnaire.So Mezaj evaluating questionnaire filled by the patient.The international sexual function questionnaire filled by this group and conclusions will calculate.Then Iranian traditional medicine diet advice by the questionnaire offered to the patients till the calculate the rate of adherency. So call to patient done every 2 weeks for calculate rate of adherency. (Day 31) , Iranian traditional medicine questionnaire and international sexual function questionnaire filled by the patients then samen analysis was done again.(Day 60) , Iranian traditional medicine questionnaire and international sexual function questionnaire filled by the patients then samen analysis was done again.
Category
Treatment - Drugs
2
Description
Second intervention group: (first day), patients must fill the Mediterranean questionnaire. Rate of interest and fallowing of the Mediterranean diet will register by scoring system of this questionnaire.So Mezaj evaluating questionnaire filled by the patient.The international sexual function questionnaire filled by this group and conclusions will calculate.Then Mediterranean diet advice by the questionnaire offered to the patients till the calculate the rate of adherency. So call to patient done every 2 weeks for calculate rate of adherency.(Day 31) , Mediterranean diet questionnaire and international sexual function questionnaire filled by the patients then samen analysis was done again. (Day 60) , Mediterranean diet questionnaire and international sexual function questionnaire filled by the patients then samen analysis was done again.
Category
Treatment - Drugs
3
Description
Control group: At this group, patients must fill the Mezaj evaluating questionnaire.The international sexual function questionnaire filled by this group and conclusions will calculate. So call to patient done every 2 weeks for calculate rate of adherency. At the beginnig of the second month ,international sexual function questionnaire filled by the patients then samen analysis was done again.At the beginnig of the third month ,international sexual function questionnaire filled by the patients then samen analysis was done again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faqihi hospital
Full name of responsible person
Abdolreza Haghpanah
Street address
Karim Khan Zand blvd
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3232 6645
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rezaian Zade,Abbas,MD
Street address
Karim Khan Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
rezaiana@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Amir Mohammad Jaladat
Position
consultant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Karim Khan Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3234 5145
Email
drjaladat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Mohammad Jaladat
Position
consultant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Karim Khan Zand Blvd
City
Shirza
Province
Fars
Postal code
7134844119
Phone
+98 71 3234 5145
Email
Drjaladat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Ghasemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
South Iman, Sheikhi avenue
City
Shiraz
Province
Fars
Postal code
7185999349
Phone
+98 71 3632 2878
Email
alighasemi20@gmail.com
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
The participant datas withouts personal information will report
When the data will become available and for how long
6 month after sucsess print
To whom data/document is available
These datas are availabale for academic researchers
Under which criteria data/document could be used
For academic research
From where data/document is obtainable
1-Shiraz university of medical sciences, Persian medicine college,related office,call to Dr.Ghasemi Ali
2- Call to +989366545445 Dr.Ghasemi Ali
3- Email to Alighasemi20@gmail.com
What processes are involved for a request to access data/document
Take a request to alighasemi20@gmail.com and after identification of the asker, data will reported