<?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>IRCT20200701047981N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-22</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effects of herbal medicine on endometriosis</public_title>
      <acronym></acronym>
      <scientific_title>Ultrasonographic study of the effects of herbal medicine package on Endometriosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49380</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of individual blocks using rand function Excel software. The size of the blocks is 4, Blinding description: The radiology assistant, who is also the lead researcher and evaluator of the outcome, along with the participants in the study, as well as the clinical caregiver who specializes in Iranian medicine, as well as the analyst, are all blind. The same package is randomly provided to patients without knowing the contents of the package.</study_design>
      <phase>3</phase>
      <hc_freetext>Endometriosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in addition to being treated with routine OCP  by a gynecologist, two Aslagh capsules of 500 mg are taken on an empty stomach in the morning (half an hour before breakfast) and two tablespoons at the end of the night. They are not taken during menturation. Abdominal anointment with chamomile oil will also be done. The duration of treatment will be three months. Aslagh product ingredients: aslagh, fennel, yellow carrot seeds. Ingredients of syrup product: fennel root and seeds, chicory root and seeds, celery seed, cucumber seed, badrang cucumber seeds, melon seed, vinegar , Water, red sugar. Intervention 2: Control group: In addition to routinr OCP  treatment prescribed by a gynecologist, which is in the form of a capsule that is similar to the drug (with the coordination of the pharmaceutical company in the same capsules, flour is poured) and to replace the placebo for the drug syrup similar syrup will be is used.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Manoosian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alam al-Huda St., Shahid Shiroodi St.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>mohamadmanoosian@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Manoosian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alam al-Huda St., Shahid Shiroodi St.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>mohamadmanoosian@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 15 to 49 years old
Endometrial disease with ovarian endometrioma</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dis-satisfaction
Cardiovascular disease
Thrombocytopenia
Pregnancy / breast feeding
Patient with uterus malignancy history or having history in the first degree family
Diabetes mellitus</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis of ovary</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: in addition to being treated with routine OCP  by a gynecologist, two Aslagh capsules of 500 mg are taken on an empty stomach in the morning (half an hour before breakfast) and two tablespoons at the end of the night. They are not taken during menturation. Abdominal anointment with chamomile oil will also be done. The duration of treatment will be three months. Aslagh product ingredients: aslagh, fennel, yellow carrot seeds. Ingredients of syrup product: fennel root and seeds, chicory root and seeds, celery seed, cucumber seed, badrang cucumber seeds, melon seed, vinegar , Water, red sugar</i_keyword>
      <i_keyword>Control group: In addition to routinr OCP  treatment prescribed by a gynecologist, which is in the form of a capsule that is similar to the drug (with the coordination of the pharmaceutical company in the same capsules, flour is poured) and to replace the placebo for the drug syrup similar syrup will be is used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ovarian endometrimal cyst size. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dysmenorrhea. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Asking patient (yes/ no).</sec_outcome>
      <sec_outcome>Pelvic pain. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Asking patient (yes/ no).</sec_outcome>
      <sec_outcome>Dysparonia. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Asking patient (yes/ no).</sec_outcome>
      <sec_outcome>Dysuria. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Asking patient (yes/ no).</sec_outcome>
      <sec_outcome>Spotting. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Asking patient (yes/ no).</sec_outcome>
      <sec_outcome>Hypermenorrhea. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Asking patient (yes/ no).</sec_outcome>
      <sec_outcome>Chronic fatigue. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Asking patient (yes/ no).</sec_outcome>
      <sec_outcome>Hematuria. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Asking patient (yes/ no).</sec_outcome>
      <sec_outcome>Painful defecation. Timepoint: At the beginning of the study and 3 months after starting the package of herbal medicines. Method of measurement: Asking patient (yes/ no).</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-14</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Alam al-Huda St., Shahid Shiroodi St. Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
