<?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>IRCT20200113046115N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-21</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Matricaria Chamomile  and Rhus Coriaria on some  Uterine Fibroma Symptoms  in Women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Matricaria Chamomile  and Rhus Coriaria on Some  Uterine Fibroma Symptoms  in Women with fibroid diseases</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>183</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45154</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Divide the block into three groups A, B, C and each letter is randomly assigned to the sumac, chamomile, and placebo group. The letters are then grouped into 6 (1: ABC, 2: ACB, 3: BAC, 4: BCA, 5: CBA, 6: CAB)  and A number is randomly selected from 1 to 6, indicating the order of allocation of the first three individuals in the groups. Again, 1 to 6 numbers are selected at random. The order of assignment of individuals to groups is specified at each time, Blinding description: In this study, the capsules of the same size and color in dark color packages will be prepared by the pharmacology unit of Shiraz University of Medical Sciences.Medicines with specific codes that only the pharmacist is aware of and The researcher is the prescriber and the participant is unaware.The data analyzer is also uninformed. In this study, only the pharmacist is aware of the type of medication.</study_design>
      <phase>3</phase>
      <hc_freetext>Uterine Fibroma.</hc_freetext>
      <i_freetext>Intervention 1: 500 mg Matricaria chamomile capsule standardized by Barij Essence Company and packaged by Shiraz University of Medical Sciences Pharmacology Unit and medication duration three times daily for two menstrual cycles for the first seven days of menstruation. Intervention 2: The 500 mg Sumac Rus Coriaria  capsule is standardized and packaged by the Shiraz University of Medical Sciences Pharmacology Unit and is administered three times daily during the first seven menstrual cycles of the menstrual cycle. Intervention 3: Control group:  500 mg placebo capsule containing cellulose powder packaged by Shiraz University of Medical Sciences pharmacology unit and drug administration three times daily during two menstrual cycles for the first seven days of menstruation.</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:
After analyzing the data and after Identifying people, part of the data will be available as a pdf file

When:
3 Month After Finish of Study

To whom:
Researchers are working in university centers

Conditions:
No data can be used under any circumstances

Where to obtain:
Referring to Professor Marziyeh Akbarzadeh

How to obtain:
Visit the Faculty of Nursing and Midwifery of Professor Akbarzadeh's office

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marziyeh Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Midwifery and Nursing, Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1978</zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>AKBARZADEHMARZIEH@YAHOO.COM</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>6 Block, Eram Dormitory, Eram sq</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111111111</zip>
        <telephone>+98 77 3425 0884</telephone>
        <email>maryam.jafari9170@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with Fibroid Disease Confirmed by a Gynecologist
Women who are willing to Cooperate and Submit Their Written Consent
Not taking any Hormonal Medication
The patient is not involved in any other diseases, including thyroid disease, endometriosis, adenomyosis and malignancies, etc. (Based on patient records)
Don't be pregnant
Don't be lactating
Not Allergic to Chamomile and Sumac and Mefenamic Acid
No History of Gastrointestinal, liver, Brain and Kidney Disease and Coagulation disorders
Body Mass Index 19-29
Age range 20-49 years
No history of prolonged constipation</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>500 mg Matricaria chamomile capsule standardized by Barij Essence Company and packaged by Shiraz University of Medical Sciences Pharmacology Unit and medication duration three times daily for two menstrual cycles for the first seven days of menstruation.</i_keyword>
      <i_keyword>The 500 mg Sumac Rus Coriaria  capsule is standardized and packaged by the Shiraz University of Medical Sciences Pharmacology Unit and is administered three times daily during the first seven menstrual cycles of the menstrual cycle.</i_keyword>
      <i_keyword>Control group:  500 mg placebo capsule containing cellulose powder packaged by Shiraz University of Medical Sciences pharmacology unit and drug administration three times daily during two menstrual cycles for the first seven days of menstruation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Moderate to severe pain. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Pain measurement by using  visual analogue scale.</prim_outcome>
      <prim_outcome>Bleeding includes menorrhagia and menometrorrhagia. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Using a pictorial blood assessment chart, patient with  the bleeding score higher than 100 will study The pre-study and post-study scores will be compared.</prim_outcome>
      <prim_outcome>Frequent urination more than 7 times a day. Timepoint: Before intervention and 2 months after intervention. Method of measurement: urination  will be entered into the study more than 7 times a day and the number of urination  before and after the intervention will be questioned and recorded and compared by the patient.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-31</approval_date>
        <contact_name>Ethics Committee of shiraz university of medical science</contact_name>
        <contact_address>Central building of Shiraz university of Medical Science ,Zand Ave,Across Palestin Street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
