<?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>IRCT20210720051946N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Montelukast  administration on rhabdomyolysis state</public_title>
      <acronym></acronym>
      <scientific_title>The effect of routine rhabdomyolysis treatment with and without concomitant administration of Montelukast on the stop progression and recovery time of rhabdomyolysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60609</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Through the table of numbers:  60 patients who have enough criteria for participation in this plan are written from number one to 60 then even numbers enter the intervention group and odd numbers enter the control group, Blinding description: For this study, patients  with rhabdomyolysis (CPK&gt; 1000) was selected from poisoning ward at Loghman Hakim Hospital in Tehran and divided into control and target groups:
1-Control group will receive routine rhabdomyolysis treatment  by hydration therapy and bicarbonate therapy
2- Target group will receive hydration therapy with oral Montelukast or gavage at a dose of 10 mg twice daily.
In this study, patients or their companions who enter the study are given consent to prescribe a new drug, but the control and target groups remain unaware of the type of treatment received and are kept blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Rhabdomyolysis.</hc_freetext>
      <i_freetext>Intervention 1: Control group:Includes odd numbers in the numbered list of patients undergoing routine rhabdomyolysis (24-hour maintenance fluid therapy plus one liter of Normal saline per 1000 units of Cpk increase above 1000) while maximal normal saline is added intake is 4 liters in 24 hours. In cases of Cpk&gt; 5000 , patients will receive only an infusion of 200 cc of 5% dextrose serum with 30 milliequivalents of Sodium bicarbonate per hour.Nephrology consultation will be performed for all patients and according to the Nephrologist, the patients who are candidates for dialysis for any reason will be removed from the plan and another patient will be replaced. Intervention 2: Intervention group: Includes even numbers in the numbered list of patients receiving treatment in the control group, but in addition, Montelukast tablets are taken as 10 mg every 12 hours orally or by gavage until the Cpk is reduced to less than 1000. This group patients, like the control group, if for any reason, according to the Nephrologist, are candidates for dialysis, they will be excluded from the plan and another patient will be replaced.</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:
Data are age, sex, and test results of the control and target groups, and only part of the data can be shared

When:
Access will start from the time the results are printed

To whom:
Everyone

Conditions:
Allowed for scientific and medical uses

Where to obtain:
Email:peyman1346erfan@sbmu.ac.ir

How to obtain:
Email:peyman1346erfan@sbmu.ac.ir
The applicant states the reason for her request by sending her request to the above email, and then within about two weeks, the general information of the patients without mentioning their names and details and the results of this research will be sent to him.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Peyman Erfantalab Avini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Special Ave., Tehran city</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333635445</zip>
        <telephone>+98 21 5102 5000</telephone>
        <email>peyman1346erfan@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Peyman Erfantalab Avini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Special Ave., Tehran city</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333635445</zip>
        <telephone>+98 21 5102 5000</telephone>
        <email>peyman1346erfan@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients that  admit  with drug or substance toxicity  and  progress to rhabdomyolysis</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rhabdomyolysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group:Includes odd numbers in the numbered list of patients undergoing routine rhabdomyolysis (24-hour maintenance fluid therapy plus one liter of Normal saline per 1000 units of Cpk increase above 1000) while maximal normal saline is added intake is 4 liters in 24 hours. In cases of Cpk&gt; 5000 , patients will receive only an infusion of 200 cc of 5% dextrose serum with 30 milliequivalents of Sodium bicarbonate per hour.Nephrology consultation will be performed for all patients and according to the Nephrologist, the patients who are candidates for dialysis for any reason will be removed from the plan and another patient will be replaced.</i_keyword>
      <i_keyword>Intervention group: Includes even numbers in the numbered list of patients receiving treatment in the control group, but in addition, Montelukast tablets are taken as 10 mg every 12 hours orally or by gavage until the Cpk is reduced to less than 1000. This group patients, like the control group, if for any reason, according to the Nephrologist, are candidates for dialysis, they will be excluded from the plan and another patient will be replaced.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cpk. Timepoint: Daily. Method of measurement: Labratory.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-22</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Aarabi Ave.,Velenjak.,Tehran City Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
