<?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>IRCT20191104045328N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-21</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>effect of Omega 3 on UTI</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of Omega 3 on UTI (Cystitis and pyelonephritis)  Symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76763</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced, Blinding description: This study is double blind. In this way, the intervention group will receive omega-3 along with routine treatment for urinary infection, while the placebo group will receive a similar placebo instead of omega-3. Therefore, the participants do not know the type of medicine received. On the other hand, prescribing the drugs is the responsibility of the supervisor, and the student, who evaluates the information, does not know about the grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>Urinary tract infection.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving standard treatment (antibiotic suitable for symptoms, age and gender), children will receive mercury-free Omega-3 capsules produced by Zahrawi company for 10 days. Intervention 2: Control group: In this group, children will receive only the standard treatment for 10 days.</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 conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.

When:
Access will be from 2024/09/20 to 2027/09/20 for 3 years.

To whom:
University researchers

Conditions:
Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.

Where to obtain:
Academic researchers and university professors can request the use of data from Dr. Manijeh Kohbazi after contacting the relevant professor by message or email. Dr. Manijeh Kohbazi: Phone: 09181614351 Email: m_kahbazi77@yahoo.com Address: Arak, Amir Kabir Hospital, Hospital Education Vice-Chancellor

How to obtain:
Letter writing should be done with professors and universities.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Manijeh Kahbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819691187</zip>
        <telephone>+98 86 3222 2003</telephone>
        <email>m_kahbazi77@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Parsa Yousefi Chaijan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819691187</zip>
        <telephone>+98 86 3222 2003</telephone>
        <email>parsayousefichaijan@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children 4-18 years old with urinary tract infection
Consent to participate in the study</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of underlying kidney and liver disease
Sensitivity to omega-3</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Urinary tract infection, site not specified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to receiving standard treatment (antibiotic suitable for symptoms, age and gender), children will receive mercury-free Omega-3 capsules produced by Zahrawi company for 10 days.</i_keyword>
      <i_keyword>Control group: In this group, children will receive only the standard treatment for 10 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fever. Timepoint: The beginning and end of treatment. Method of measurement: Mercury Therommeter.</prim_outcome>
      <prim_outcome>Dysuria. Timepoint: The beginning and end of treatment. Method of measurement: Take a history.</prim_outcome>
      <prim_outcome>Frequency. Timepoint: The beginning and end of treatment. Method of measurement: Take a history.</prim_outcome>
      <prim_outcome>Abdominal pain. Timepoint: The beginning and end of treatment. Method of measurement: Take a history.</prim_outcome>
      <prim_outcome>Urinary incontinence. Timepoint: The beginning and end of treatment. Method of measurement: Take a history.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-31</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
