<?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>IRCT20181118041689N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-24</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of melatonin and atorvastatin on diabetic nephropathy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of co-administration of melatonin and atorvastatin in type II diabetic patients with microalbuminuria</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35292</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random number table and block randomization method will be used using http://www.randomizer.org.In this method, eligible patients are divided into blocks of 4 patients. We create random numbers using computer.Based on the determined numerical range to enter individuals in each group, half of the patients in each block will receive atorvastatin (20 mg) and placebo and half of them receive atorvastatin (20 mg) and Melatonin (3 mg), Blinding description: Participants, the person who puts the medication in cans and labels on the cans, the person who selects and enrols the eligible patients, A person who blocks patients and determines the allocation of medications to patients, the doctor who gives the medications to the patients, data collection authorities, those who evaluate the outcome and those who prepare the draft article do not know what kind of drugs are in each can.</study_design>
      <phase>3</phase>
      <hc_freetext>Type 2 diabetes mellitus with kidney complication.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Patients with type II diabetes who have microalbuminuria and receive atorvastatin (20 mg) and placebo once a day for 6 months. Intervention 2: Intervention group: Patients with type II diabetes who have microalbuminuria and receive at the same time atorvastatin (20 mg) and Melatonin (3 mg) once a day for 6 months.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Hosseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 3134</telephone>
        <email>azam.hosseinzade@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Hosseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 3134</telephone>
        <email>azam.hosseinzade@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with type II diabetes
Diabetic patient over 40 years of age.
Patients with microalbuminuria (urinary albumin 30- 300 mg/24h)
Patients who sign a written informed consent form.
Patients with HbA1c of &lt; 8%</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with blood pressure &gt; 160 ⁄ 90 mmHg
Patients with statins intolerance.
Patients with statin-inducedmyopathy
Patients who have used immunosuppressive drugs within 3 months of the first screening visit.
Patients with intolerance to blood pressure reducing drugs (e.g., angiotensin II receptor-blocking drugs)
Patients with other illness likely to influence the trial such as congestive heart failure, hypothyroidism, severe kidney failure, polycystic kidney disease, HIV nephropathy, ischemic kidney disease, interstitial nephritis of idiopathic kidney and hepatic failure
Patients who have been kidney transplant in the past.
Patients who have taken part in other clinical trials in the last 3 months.
Patients who are pregnant or breast-feeding.
Patients who are researchers and co-workers in this trial.
Patients with a history of alcohol abuse or smoking.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with kidney complications</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>Control group: Patients with type II diabetes who have microalbuminuria and receive atorvastatin (20 mg) and placebo once a day for 6 months.</i_keyword>
      <i_keyword>Intervention group: Patients with type II diabetes who have microalbuminuria and receive at the same time atorvastatin (20 mg) and Melatonin (3 mg) once a day for 6 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urine albumin to creatinine ratio. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Measuring creatinine and albumin levels in urine using biochemical tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glomerular filtration rate (GFR). Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: The measurement is based on the results of blood creatinine, urine creatinine and 24-hour urine volume.</sec_outcome>
      <sec_outcome>Serum creatinine. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.</sec_outcome>
      <sec_outcome>Blood triglyceride level. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.</sec_outcome>
      <sec_outcome>Blood level of HDL cholesterol. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.</sec_outcome>
      <sec_outcome>Blood level of LDL cholesterol. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.</sec_outcome>
      <sec_outcome>Blood level of total cholesterol. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.</sec_outcome>
      <sec_outcome>The level of fasting blood glucose. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.</sec_outcome>
      <sec_outcome>The level of Blood Urea Nitrogen (BUN). Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-12</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
