<?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>IRCT20191127045517N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-18</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>The effect of oral evening primrose oil capsule on sexual function of women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of oral evening primrose oil capsule on sexual function and sexual quality of life of married women in reproductive ages: A double-blinded randomized placebo-controlled trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44313</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be use for randomizing participants within blocks such that an equal number will assigned to treatment. we will give a block size of 4, which there are 6 possible ways to equally assign participants to a block. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence, Blinding description: In this study, the researcher and the study participants will not aware of the drug or placebo.</study_design>
      <phase>1</phase>
      <hc_freetext>Sexual dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 30 women who will be  included in the study according to inclusion criteria. They will consume 1 capsule of 1000 mg oral evening primrose oil daily prepared by barij esans Company for 8 weeks. Following the intervention, the researcher will contact the research units in the intervention group each week to ensure proper use of the evening primrose oil capsule. Evaluation of the research units will be done 4 weeks after the intervention using the questionnaires completed by the research units in person. Intervention 2: Control group: 30 women who will be included in the study according to inclusion criteria. They will consume 1placebo capsule of 30 mg daily prepared by barij esans Company for 8 weeks. Following the intervention, the researcher will contact the research units in the intervention group each week to ensure proper use of the placebo capsule. Evaluation of the research units will be done 4 weeks after the intervention using the questionnaires completed by the research units in person.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shadab Shahali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical Sciences, Tarbiat Modares University, Jalal al Ahmad St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3811</telephone>
        <email>shadab.shahali@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shadab Shahali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical Sciences, Tarbiat Modares University, Jalal al Ahmad St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3811</telephone>
        <email>shadab.shahali@modares.ac.ir</email>
        <affiliation>Tarbiat modares university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women over the age of 18 (age 18 is considered a good time for marriage) and before the age of pre-menopause (49 years).
Being Iranian and living in Tehran
Reading and Writing Persian Language
participants who had a monogamous husband during the study and at the beginning of it
Having sex in the last two months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a known underlying disease
Couples are addicted to drugs and alcohol
Having a history of pelvic surgery
pregnancy or breastfeeding
Having a mental illness
Sensitive to evening primrose oil
Taking drugs that affect sexual function
Have a stressful accident over the past month
Have a urinary tract infection
Having vaginitis, cervicitis, pelvic genital pain disorders, active sores or genital lesions that interfere with sexual intercourse (penetration)
Victims of rape
having the history of infertility</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction not due to a substance or known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 30 women who will be  included in the study according to inclusion criteria. They will consume 1 capsule of 1000 mg oral evening primrose oil daily prepared by barij esans Company for 8 weeks. Following the intervention, the researcher will contact the research units in the intervention group each week to ensure proper use of the evening primrose oil capsule. Evaluation of the research units will be done 4 weeks after the intervention using the questionnaires completed by the research units in person.</i_keyword>
      <i_keyword>Control group: 30 women who will be included in the study according to inclusion criteria. They will consume 1placebo capsule of 30 mg daily prepared by barij esans Company for 8 weeks. Following the intervention, the researcher will contact the research units in the intervention group each week to ensure proper use of the placebo capsule. Evaluation of the research units will be done 4 weeks after the intervention using the questionnaires completed by the research units in person.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Female sexual function. Timepoint: Evaluation of research units will be done 4 and 8 weeks after the intervention. Method of measurement: Female sexual function index.</prim_outcome>
      <prim_outcome>Sexual Quality of Life. Timepoint: Evaluation of research unitswill be don 4 and 8 weeks after the intervention. Method of measurement: Sexual Quality of Life-Female (SQOL-F) questionnaire.</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-17</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modarres University</contact_name>
        <contact_address>Faculty of Medicine, Tarbiat Modares University, Jalal al Ahmad high way Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
