<?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>IRCT20230111057113N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-23</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the efficacy  of D-Chiro-Inositol in endometriosis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the efficacy  of D-Chiro-Inositol in pain relif  in endometriosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68717</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly given a sealed envelope containing medicine, Blinding description: Patients will be randomly divided into two equal groups.The patients are discussed about the research plan and the method, the goals and the results obtained and An attempt is made to obtain the consent of the patients to participate in the study.Written consent is obtained from patients who agree to participate and Then they will be divided into case and control groups.In a random and double-blind manner, the medicine packages will be distributed by the doctor between the two groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Endometriosis is characterized by the presence of endometrial and stromal tissue outside the uterine cavity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: two  tablets containing 1200 mg of DCI and 120 mg of alpha-lactalbumin for the first month and 600 mg of DCI and 60 mg of alpha-lactalbumin for the next 5 months. Intervention 2: Control group: Control group: tablets containing 600 mg of maltodextrin daily for 6 months.</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:
Only a part of the data, such as the information related to the main result or the like, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
For scientific studies and therapeutic use

Where to obtain:
Samaneh Esmaeili،dresmaeili@gmail.com

How to obtain:
Within a month of receiving the email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Esmaeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital,Next to Shahid Beheshti University of Medical Sciences,Shahid Arabi St,Yemen St ,Shahid Chamran Highway ,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2243 2560</telephone>
        <email>dresmaeili@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Esmaeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital,Next to Shahid Beheshti University of Medical Sciences,Shahid Arabi St,Yemen St ,Shahid Chamran Highway ,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2243 2560</telephone>
        <email>dresmaeili@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 40 years old
Diagnosis of endometriosis
Refusal  to use other standard therapies
Systemic estradiol &gt;90 pg/ml during the first 4 days after the end of menstrual cycle.
informed consent to entry
Pelvic pain that has been present for at least three months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosis of secreting tumors
previous history of Diabetes Melitus
BMI&gt;30
Taking hormones or inositol within 6 months before starting the study
Using other drugs, especially (OCP and...)
Any disease that interferes with the use of D-chiroinositol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis</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: two  tablets containing 1200 mg of DCI and 120 mg of alpha-lactalbumin for the first month and 600 mg of DCI and 60 mg of alpha-lactalbumin for the next 5 months.</i_keyword>
      <i_keyword>Control group: Control group: tablets containing 600 mg of maltodextrin daily for 6 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pelvic pain. Timepoint: At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment. Method of measurement: VAS score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pelvic pain. Timepoint: At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment. Method of measurement: VAS  score.</sec_outcome>
      <sec_outcome>Dyspareunia. Timepoint: At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment. Method of measurement: Vas score.</sec_outcome>
      <sec_outcome>Dysmenorrhea. Timepoint: At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment. Method of measurement: Vas score.</sec_outcome>
      <sec_outcome>Dyschezia. Timepoint: At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment. Method of measurement: Vas score.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-20</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Taleghani hospital, Next to Shahid Beheshti University of Medical Sciences,Shahid  Arabi St    ,Yemen St, Chamran Highway,Tehran ،ehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
