<?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>IRCT20220817055727N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of N-acetyl cysteine(NAC) and vitamin C in patients with endometriosis</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of N-acetyl cysteine(NAC) and vitamin C in patients with endometriosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71458</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Endometriosis.</hc_freetext>
      <i_freetext>Intervention 1: In this study, people are divided into 3 intervention groups; Before and 12 weeks after the treatment, with the patient's consent, the serum levels of IL-6 and TNFα are checked with an ELISA device, ultrasound of the abdomen and pelvis to detect endometriosis lesions, as well as pain intensity using the VAS questionnaire. Intervention 2: Intervention group: The first intervention group (group I) is given vitamin C (1000 mg per day). Intervention 3: Intervention group: The second intervention group (group II) is given N-acetylcysteine ​​(600 mg per day). Intervention 4: Intervention group: The third intervention group (group III) is given a combination of N-acetylcysteine ​​(600 mg per day) and vitamin C (1000 mg per day).</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:
Part of data like the main outcome or the same will be shared.

When:
Access after 6 months after publication

To whom:
Data will be available for all researchers.

Conditions:
It is important for further research and identification of markers in reducing patients' pain that can be used later in the pharmaceutical industry.

Where to obtain:
For receiving data please be contacted with shchaichian@gmail.com.

How to obtain:
limitless

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Shahla Chaichian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St., Ayane Blvd., Amir Pabarja St., Qolhek Road, Doktor Shariati St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1949635881</zip>
        <telephone>+98 21 2660 2642</telephone>
        <email>shchaichian@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Shahla Chaichian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St., Ayane Blvd., Amir Pabarja St., Qolhek Road, Doktor Shariati St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1949635881</zip>
        <telephone>+98 21 2660 2642</telephone>
        <email>shchaichian@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age group 18-35 years old • No menopause • Definitive diagnosis of endometriosis in the last 10 years • Experience of moderate to severe pain (pain score 6-7) • Patients who have resisted common endometriosis treatments or did not respond well to previous treatments. • Written patient consent.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>history of chronic pelvic pain that was not due to endometriosis. History of autoimmune, cardiovascular and kidney diseases according to the patient. Abnormal liver enzymes. History of osteoporosis according to the patient. History of other metabolic diseases, including diabetes, dyslipidemia, and metabolic syndrome according to his tests • Simultaneous reception of steroid hormones in different pharmaceutical forms and various doses in the last 3 months • Simultaneous reception of GnRH analogs in the last 3 months • Simultaneous reception of systemic glucocorticoids in the last 3 months • Lack of patient satisfaction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis, unspecified</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, people are divided into 3 intervention groups; Before and 12 weeks after the treatment, with the patient's consent, the serum levels of IL-6 and TNFα are checked with an ELISA device, ultrasound of the abdomen and pelvis to detect endometriosis lesions, as well as pain intensity using the VAS questionnaire.</i_keyword>
      <i_keyword>Intervention group: The first intervention group (group I) is given vitamin C (1000 mg per day).</i_keyword>
      <i_keyword>Intervention group: The second intervention group (group II) is given N-acetylcysteine ​​(600 mg per day).</i_keyword>
      <i_keyword>Intervention group: The third intervention group (group III) is given a combination of N-acetylcysteine ​​(600 mg per day) and vitamin C (1000 mg per day).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Before and 12 weeks after treatment. Method of measurement: Vas score questionnaire.</prim_outcome>
      <prim_outcome>Interleukin-6. Timepoint: Before and 12 weeks after treatment. Method of measurement: ELISA reader device.</prim_outcome>
      <prim_outcome>TNFα. Timepoint: Before and 12 weeks after treatment. Method of measurement: ELISA reader device.</prim_outcome>
      <prim_outcome>Abdominal and pelvic ultrasound findings. Timepoint: Before and 12 weeks after treatment. Method of measurement: Ultrasound device.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-17</approval_date>
        <contact_name>Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences</contact_name>
        <contact_address>13th floor, Block A, Ministry of Health, Treatment and Medical Education headquarters, Simaye Iran St, between South Flamak and Zarafshan, Quds settlement (Gharb), Tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
