<?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>IRCT20230125057222N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-19</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Nigella sativa oil in patients with polycystic ovary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sativa Nigella sativa oil on serum levels of IL-6, TNF- alpha, insulin and lipid profiles in patients with polycystic ovarian syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68707</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using envelopes (A and B) containing medicine and placebo, they will be randomly divided into two groups. Based on the calculated sample size, 30 envelopes A and 30 envelopes B are placed in a lottery container, and then the envelopes are randomly removed from the container without replacement and the created sequence will be recorded, Blinding description: In this study, double-blind will be used so that the patient and the student who provides the envelope to the patient will be blind to the content of the envelopes (intervention or placebo).</study_design>
      <phase>3</phase>
      <hc_freetext>Polycystic ovary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:subjects receiving black seed oil. In this group, subjects will receive capsules containing black seed oil with a dose of 1000 mg per day orally for three months. Black seed oil capsules will be provided by Barij Essential Oil Company (Kashan). Intervention 2: Control group: Subjects receiving placebo capsules. In this group, subjects will receive capsules containing placebo, which are similar to capsules containing black seed oil in terms of shape, color and side ingredients, orally daily for three months. Placebo capsules will be provided from Barij Essan Company (Kashan).</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 Access to patient information is confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faranak Jalilvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports field - Alavi Hospital</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5613974156</zip>
        <telephone>+98 45 3324 8888</telephone>
        <email>faran.jalil@gmail.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faranak Jalilvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports field - Alavi Hospital</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5613974156</zip>
        <telephone>+98 45 3324 8888</telephone>
        <email>faran.jalil@gmail.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Oligomenorrhea or lack of ovulation
Polycystic ovaries based on ultrasound
Androgenic hormone changes in laboratory or clinical form (the presence of hirsutism)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Type 2 diabetes -
thyroid disease -
adrenal hyperplasia
autoimmune diseases -
- hyperprolactinemia
People with structured physical activity or scheduled exercise
If three months before entering the study, they use a special diet or special drugs that may affect the results, they will be excluded from the study, such as anti-obesity drugs, ovulation stimulants, antidepressants, insulin sensitivity, oral contraceptives, aspirin, and Anti-prostaglandin drugs
If there are signs of pregnancy, they will be excluded from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome</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:subjects receiving black seed oil. In this group, subjects will receive capsules containing black seed oil with a dose of 1000 mg per day orally for three months. Black seed oil capsules will be provided by Barij Essential Oil Company (Kashan).</i_keyword>
      <i_keyword>Control group: Subjects receiving placebo capsules. In this group, subjects will receive capsules containing placebo, which are similar to capsules containing black seed oil in terms of shape, color and side ingredients, orally daily for three months. Placebo capsules will be provided from Barij Essan Company (Kashan).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Interleukin 6,. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.</prim_outcome>
      <prim_outcome>TNF-alpha. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin resistance index (QUICKI), insulin sensitivity index (HOMA-IR). Timepoint: Before and 12 weeks after the intervention. Method of measurement: Calculation of indices.</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-21</approval_date>
        <contact_name>Ethics Committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Faculty of Medicine, 1st floor, University Street, 8599156189, Ardabil, Iran Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
