<?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>IRCT20190527043729N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-28</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>effect of a combinatory medication on the basis of black seed on the sexual function of women.</public_title>
      <acronym></acronym>
      <scientific_title>Topical effect an oil, derived from black seed, on women's sexual function: A pilot clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39880</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Sexual dysfunction. Condition 2: Lack or loss of sexual desire. Condition 3: Lack or loss of sexual enjoyment. Condition 4: Lack or loss of female sexual arousal disorder.</hc_freetext>
      <i_freetext>Intervention group: The study consists of one group and the intervention is the same for all. 40 women with an age range of 18- 35 years with sexual dysfunction are selected for the study, according to inclusion and non-inclusion criteria. The duration of the intervention period is 14 days. In order to evaluate the patients, the female sexual function index (FSFI) is completed during each examination session. in the first and second stage, they will receive medication. the name of the medicinal product: olibanum oil. product description: a topical product based on black seed oil containing olibanum and olive oil. Company Name: Amir herbal medicine. Medication instructions for use: The medication is used locally every night before bedtime, and once before intercourse in the area of the sex organs, inguinal area, low back, and soles. Time of drug use: from the 14th day of the menstrual bleeding cycle, the nights before bedtime for 14 days and, once before any Sexual Intercourse..</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:
All potential data can be shared after being unidentified.

When:
The start of the access period will be 6 months after the publication of the results.

To whom:
Data will only be available to researchers working in academic and academic institutions.

Conditions:
Data will only be available for use in research articles and will not be publicly available in any other way.

Where to obtain:
Please refer to the Faculty of Traditional Medicine of Tehran University of Medical Sciences for documentation and data.
 Dr. Meysam Shirzad, Assistant Professor, Department of Iranian Medicine.
address: no 27., Sarparast Ave., taleghni Ave.
Contact number: 02188974535
Electric mail: shirzadmd@gmail.com

How to obtain:
The data will be available from the time the application is filed to the person responsible for the scientific evidence of the person requesting that the researcher working in the university and the study of the relevant study.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Ghanbaryan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 68, Milad Line, Edalat Ave.,</address>
        <city>Behbahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6361778538</zip>
        <telephone>+98 61 5283 2978</telephone>
        <email>lghanbaryan@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shirzad Meysam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 27, Sarparast Ave., Taleghni St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8897 4535</telephone>
        <email>shirzadmd@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women with a stable life with their spouse
having the least reading and writing education skills.
having intercourse of three times or more during the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosis of chronic physical, psychological and behavioral illnesses.
being multi-partner
using hormonal drugs and drugs affecting sexual function.
pregnancy, lactation, and menopause.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
      <hc_code>F52.0</hc_code>
      <hc_code>F52.1</hc_code>
      <hc_code>F52.22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction not due to a substance or known physiological condition</hc_keyword>
      <hc_keyword>Hypoactive sexual desire disorder</hc_keyword>
      <hc_keyword>Sexual aversion disorder</hc_keyword>
      <hc_keyword>Female sexual arousal disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The study consists of one group and the intervention is the same for all. 40 women with an age range of 18- 35 years with sexual dysfunction are selected for the study, according to inclusion and non-inclusion criteria. The duration of the intervention period is 14 days. In order to evaluate the patients, the female sexual function index (FSFI) is completed during each examination session. in the first and second stage, they will receive medication. the name of the medicinal product: olibanum oil. product description: a topical product based on black seed oil containing olibanum and olive oil. Company Name: Amir herbal medicine. Medication instructions for use: The medication is used locally every night before bedtime, and once before intercourse in the area of the sex organs, inguinal area, low back, and soles. Time of drug use: from the 14th day of the menstrual bleeding cycle, the nights before bedtime for 14 days and, once before any Sexual Intercourse.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of sexual function based on Female sexual function index questionnaire. Timepoint: Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day,  After starting the oil based on black seed. Method of measurement: Female sexual function index questionnaire.</prim_outcome>
      <prim_outcome>Score of sexual desire or interest based on Female sexual function index questionnaire. Timepoint: Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day,  After starting the oil based on black seed. Method of measurement: Female sexual function index questionnaire.</prim_outcome>
      <prim_outcome>Score of satisfied in sexual relationship based on Female sexual function index questionnaire. Timepoint: Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day,  After starting the oil based on black seed. Method of measurement: Female sexual function index questionnaire.</prim_outcome>
      <prim_outcome>Score of sexual arousal based on Female sexual function index questionnaire. Timepoint: Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day,  After starting the oil based on black seed. Method of measurement: Female sexual function index questionnaire.</prim_outcome>
      <prim_outcome>Score of maintain vaginal lubrication until completion of intercourse based on Female sexual function index questionnaire. Timepoint: Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day,  After starting the oil based on black seed. Method of measurement: Female sexual function index questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Skin itching. Timepoint: On the seventh day, and on the 14th day,  After starting the oil based on black seed. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Skin irritation. Timepoint: On the seventh day, and on the 14th day,  After starting the oil based on black seed. Method of measurement: Observation.</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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-09</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Scienes</contact_name>
        <contact_address>Alborz University of Medical Sciences, Official Town, North Taleghani Blvd. KARAJ Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
