<?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>IRCT20221211056777N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-18</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of curcumin capsules on cisplatin-induced kidney damage</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the Effect of Curcumin Capsules on Prevention of Nephropathy Caused by Chemotherapy with Cisplatin( double blind clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68514</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 50 cancer patients referring to Hajar Shahrekord Hospital are divided into two groups of 25 each by the permutation block randomization method with a size of 10. The randomization list will be prepared by random allocation software and people will be assigned to groups named A and B, Blinding description: This study will be conducted in a double-blind manner. The objectives of the study will be explained to the participants. In order to blind the patients, curcumin and placebo capsules will be prepared from the same company in similar packaging. The participants will not know which intervention group they are in. Also, the researcher is not aware of the contents of the medicine package.</study_design>
      <phase>3</phase>
      <hc_freetext>cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cancer patients treated with cisplatin who will receive 80 mg curcumin capsules (Sina Curcumin Company) 2 times a day for 9 weeks. Intervention 2: Control group: Cancer patients treated with cisplatin who will placebo capsules (Sina Curcumin Company) 2 times a day for 9 weeks.</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:
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.

When:
The access period will start 6 months after the results are published.

To whom:
Our data will only be available to researchers working in academic and scientific institutions

Conditions:
Except for personal information about people, all of our data will be shared if certain requirements are met. Our data will only be used for comparable study and peer review by other researchers. Anyone working in universities or scientific institutions who wants to do similar study or confirm the accuracy of our data can access our data.

Where to obtain:
All qualified individuals can collect data by referring to the project manager in order to acquire information. Contact information is available via email at  shimarahmati1987@gmail.com or the contact number 00989139854865

How to obtain:
To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shima Rahmati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Street, Shahrekord, Chaharmahal va Bakhtiary, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816754633</zip>
        <telephone>+98 38 3222 0016</telephone>
        <email>shimarahmati1987@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kiavash Fekri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Street, Shahrekord, Chaharmahal va Bakhtiary, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816754633</zip>
        <telephone>0383222116</telephone>
        <email>k.fekri@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Cancer patients over 5 years of age who are being treated with cisplatin
be the same in terms of medications and supplements taken
Absence of kidney tumor
No kidney failure</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosing the presence of kidney stones in patients
Patient non-cooperation</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cancer patients treated with cisplatin who will receive 80 mg curcumin capsules (Sina Curcumin Company) 2 times a day for 9 weeks.</i_keyword>
      <i_keyword>Control group: Cancer patients treated with cisplatin who will placebo capsules (Sina Curcumin Company) 2 times a day for 9 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of sodium. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Measurement of serum sodium level with a Flame Photometer.</prim_outcome>
      <prim_outcome>Serum levels of potassium. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Measurement of serum potassium level with a Flame Photometer.</prim_outcome>
      <prim_outcome>Serum levels of calcium. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Measurement of serum calcium level with a Flame Photometer.</prim_outcome>
      <prim_outcome>Serum levels of magnesium. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Measurement of serum magnesium level with a Flame Photometer.</prim_outcome>
      <prim_outcome>Serum levels of creatinine. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Measurement of serum creatinine  level with a Flame Photometer   creatinine.</prim_outcome>
      <prim_outcome>Serum levels of blood urea nitrogen. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Measurement of serum blood urea nitrogen level with a Flame Photometer   creatinine.</prim_outcome>
      <prim_outcome>A quantitative measure of GFR. Timepoint: before the intervention and 8 weeks after the intervention. Method of measurement: Absolute measurement of glomerular filtration rate (GFR) according to creatinine clearance formula (GFR=Ucr*v/Pcr*1440).</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-27</approval_date>
        <contact_name>Ethics Committee of the School of Medicine, Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Headquarters of Shahrekord University of Medical Sciences,Kashani Street, Shahrekord, Chaharmahal va Bakhtiary, Iran Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
