<?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>IRCT20180103038199N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-14</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of carrot seed capsules on the sexual desire of female patients with multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of carrot (Daucus carota) seed capsules on the sexual desire of female patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/69083</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 10 blocks according to the sample size of 40. Then random numbers between 1 and 10 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers, Blinding description: Using sealed envelopes Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal codes A and B.</study_design>
      <phase>2</phase>
      <hc_freetext>Women suffering from multiple sclerosis complaining of lack or absence of sexual desire.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Women suffering from multiple sclerosis with complaints of lack or absence of sexual desire use 500 mg capsules containing carrot seed powder 3 times a day for 12 weeks. Intervention 2: Control group: Women suffering from multiple sclerosis with complaints of lack or absence of sexual desire use 500 mg placebo capsules similar to carrot seed capsules 3 times a day for 12 weeks.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Vahid Reza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3800 2264</telephone>
        <email>askariv@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Vahid Reza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3800 2264</telephone>
        <email>askariv@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women with multiple sclerosis
Age between 18-45
With complaints of lack or absence of sexual desire
More than 6 months have passed since their marriage
Normal pelvic examination findings
Have a normal pap smear in the last 3 years
Have access to having sex with a partner monthly for at least 15 days</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy or breastfeeding
Menopause
Any disability or serious medical problem that requires constant care and treatment
Suffering from major depressive disorder and other psychiatric disorders
Husband's sexual problems
Divorce</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypoactive sexual desire disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Women suffering from multiple sclerosis with complaints of lack or absence of sexual desire use 500 mg capsules containing carrot seed powder 3 times a day for 12 weeks.</i_keyword>
      <i_keyword>Control group: Women suffering from multiple sclerosis with complaints of lack or absence of sexual desire use 500 mg placebo capsules similar to carrot seed capsules 3 times a day for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Overall score of the FSFI questionnaire. Timepoint: At the beginning of the study and then every 4 weeks until week 12. Method of measurement: FSFI Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fatigue rate. Timepoint: At the beginning of the study and after 12 weeks of treatment. Method of measurement: MFIS fatigue assessment questionnaire.</sec_outcome>
      <sec_outcome>The level of anxiety and depression. Timepoint: At the beginning of the study and after 12 weeks of treatment. Method of measurement: Spielberger anxiety questionnaire.</sec_outcome>
      <sec_outcome>LH levels. Timepoint: At the beginning of the study and after 12 weeks of treatment. Method of measurement: Laboratory kit.</sec_outcome>
      <sec_outcome>FSH levels. Timepoint: At the beginning of the study and after 12 weeks of treatment. Method of measurement: Laboratory kit.</sec_outcome>
      <sec_outcome>Prolactin levels. Timepoint: At the beginning of the study and after 12 weeks of treatment. Method of measurement: Laboratory kit.</sec_outcome>
      <sec_outcome>Testosterone levels. Timepoint: At the beginning of the study and after 12 weeks of treatment. Method of measurement: Laboratory kit.</sec_outcome>
      <sec_outcome>CBC diff levels. Timepoint: At the beginning of the study and after 6 and 12 weeks of treatment. Method of measurement: Laboratory kit.</sec_outcome>
      <sec_outcome>Interleukin-6 levels. Timepoint: At the beginning of the study and after 12 weeks of treatment. Method of measurement: Laboratory kit.</sec_outcome>
      <sec_outcome>TNF-a levels. Timepoint: At the beginning of the study and after 12 weeks of treatment. Method of measurement: Laboratory kit.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-06</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences</contact_name>
        <contact_address>School of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
