<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210228050534N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-13</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effects of Iranian traditional medicine diets on erectile function</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effects of Iranian traditional medicine diets on erectile function and semen analysis of men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>159</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55060</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Erectile dysfunction. Condition 2: Oligospermia.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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. Intervention 3: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The participant datas withouts personal information will report

When:
6 month after sucsess print

To whom:
These datas are availabale for academic researchers

Conditions:
For academic research

Where to obtain:
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

How to obtain:
Take a request to alighasemi20@gmail.com and after identification of the asker, data will reported

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Mohammad Jaladat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karim Khan Zand Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 71 3234 5145</telephone>
        <email>drjaladat@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Mohammad Jaladat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karim Khan Zand Blvd</address>
        <city>Shirza</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 71 3234 5145</telephone>
        <email>Drjaladat@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Oligospermia
Iranian nation
Age 18-45
Consensus
Adults men
BMI 18.5-30</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Anatomical infertility findings
Prostate cancer
Heart disease
Hypertension
Diabetes mellitus
Herbal remedies use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N52</hc_code>
      <hc_code>N46.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Male erectile dysfunction</hc_keyword>
      <hc_keyword>Oligospermia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-12</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>South Iman blvd, Sheikhi avenue Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
