<?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>IRCT20150629022965N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-05</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effects of oral N-acetyl cysteine as an adjuvant therapy for pain management and serum level of oxidative stress bio-markers in patients with painful diabetic neuropathy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effects of oral N-acetyl cysteine as an adjuvant therapy for pain management and serum level of oxidative stress bio-markers in patients with painful diabetic neuropathy: a double-blind randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32816</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization, Blinding description: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind.</study_design>
      <phase>2</phase>
      <hc_freetext>Diabetic polyneuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 75 mg of pregabalin every 12 hours plus 600 mg of effervescent tablet of N-acetyl cysteine every 12 hours for 8 weeks. Intervention 2: Control group: 75 mg of pregabalin every 12 hours plus oral placebo every 12 hours for 8 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Mehrpooya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacy school, Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd., Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838678</zip>
        <telephone>+98 81 3838 0717</telephone>
        <email>m_mehrpooya2003@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Mehrpooya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacy school, Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd., Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838678</zip>
        <telephone>+98 81 3838 0717</telephone>
        <email>m_mehrpooya2003@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 30 to 70 years old
History of type 2 diabetes at least one year ago
Hemoglobin A1c less than or equal to 10
Diabetic neuropathy with NDS score greater than or equal to 6, VAS scores for pain at least 4 and NSS score greater than or equal to 5
glomerular filtration rate more than 30</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Type 1 diabetes
Pregnancy or breastfeeding
Diabetic foot ulcer
Neuropathy for reasons other than diabetes
History of cerebrovascular disease and discopathy
Use other medications to relieve symptoms of neuropathy
Use of alcoholic drinks or opioids</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with diabetic polyneuropathy</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: 75 mg of pregabalin every 12 hours plus 600 mg of effervescent tablet of N-acetyl cysteine every 12 hours for 8 weeks.</i_keyword>
      <i_keyword>Control group: 75 mg of pregabalin every 12 hours plus oral placebo every 12 hours for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of lipid peroxidation. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Serum levels of nitric oxide. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Serum levels of total antioxidant capacity. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Catalase activity. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Activity of superoxide dismutase. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Serum level of thiol. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Activity of Glutathione Peroxidase. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Numeric rating scale. Timepoint: Before intervention, weekly until end of the study. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Sleep interference score. Timepoint: Before intervention, weekly until end of the study. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Patient Global Impression of Change. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Clinical Global Impression of Change. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Questionnaire.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-09</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Pharmacy school, Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd., Hamedan Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
