<?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>IRCT2017012932277N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-19</date_registration>
      <primary_sponsor>The vice chancellor for research affairs of Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Identification of the probable mechanisms of Duloxetine and Pregabalin involving in treatment of neuropathic pain of type 2 diabetic  patients</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of duloxetine and pregabalin effects on plasma concentration of nitric oxide (NO) and inducible nitric oxide synthase (iNOS) in type 2 diabetic patients and the role of these mediators  in neuropathic pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25182</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Non-insulin-dependent diabetes mellitus. Condition 2: Pain due to diabetic polyneuropathy. Condition 3: Autonomic neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Duloxetine group:  Duloxetine 30 and 60 mg capsules, formulated by Sobhan pharmaceutical factory, Duloxetine 30 mg capsules will be prescribed once daily at first week, afterward, Duloxetine 60 mg capsules will be prescribed once daily for seven more weeks and before these eight weeks Duloxetine 30 mg  placebo capsules (manufactured by Sobhan pharmaceutical factory) will be prescribed once daily for ten days. Intervention 2: Pregabalin group: Pregabalin 75 and 150 mg  capsules, formulated by Sobhan pharmaceutical factory, Pregabalin 75 mg capsules will be prescribed twice daily at first week, afterward,  Pregabalin 150 mg capsules will be prescribed twice daily for seven more weeks and before these eight weeks Pregabalin 75 mg placebo capsules (manufactured by Sobhan pharmaceutical factory) will be prescribed twice daily for ten 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moosareza Memari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacology Department, School of Medicine, Shahid Beheshti  University of Medical Sciences, Koodakyar Avenue, Daneshjoo Blvd, Velenjak, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2387 2539</telephone>
        <email>reza_memari@sbmu.ac.ir and reza_1117@yahoo.com</email>
        <affiliation>Pharmacology Department, School of Medicine, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khojasteh Joharchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacology Department, School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar Avenue, Daneshjoo Blvd, Velenjak, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2387 2539</telephone>
        <email>joharchi-kh@sbmu.ac.ir</email>
        <affiliation>Pharmacology Deparment, School of Medicine, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
1-Type 2 diabetic patients with neuropathic pain which have the pain score over 4 on Visual Analogue Scale (VAS) for more than 3 months; 2-The age range:  40-60 years; 3- The patients should fill out and sign the consent forms&#13;
Exclusion criteria: &#13;
1-Hypersensitivity to Duloxetine and Pregabalin; 2-Kidney or liver failure; 3-Any other neuropathies (spinal cord injury, discopathy, congenital neuropathy, vocational, hypothyroidism, collagen vascular disease, vasculitis, Paraneoplastic disorders, immunological, alcoholism and drugs induced);  4- Rheumatoid Arthritis; 5-Goat; 6-Epilepsy; 7-Orthopedic complications; 8- Vision disability; 9-Intellectual disorders; 10-Usage of analgesic and anti-inflammatory drugs; 11-Type 1 diabetes; 12-Hypertension; 13-Smoking</inclusion_criteria>
      <agemin>39 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
      <hc_code>G63.2*</hc_code>
      <hc_code>G99.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
      <hc_keyword>Diabetic polyneuropathy</hc_keyword>
      <hc_keyword>Autonomic neuropathy in endocrine and metabolic diseases</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>Duloxetine group:  Duloxetine 30 and 60 mg capsules, formulated by Sobhan pharmaceutical factory, Duloxetine 30 mg capsules will be prescribed once daily at first week, afterward, Duloxetine 60 mg capsules will be prescribed once daily for seven more weeks and before these eight weeks Duloxetine 30 mg  placebo capsules (manufactured by Sobhan pharmaceutical factory) will be prescribed once daily for ten days</i_keyword>
      <i_keyword>Pregabalin group: Pregabalin 75 and 150 mg  capsules, formulated by Sobhan pharmaceutical factory, Pregabalin 75 mg capsules will be prescribed twice daily at first week, afterward,  Pregabalin 150 mg capsules will be prescribed twice daily for seven more weeks and before these eight weeks Pregabalin 75 mg placebo capsules (manufactured by Sobhan pharmaceutical factory) will be prescribed twice daily for ten days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plasma concentration of Nitric Oxide Synthase. Timepoint: Before drug prescription and on days 30 and 60 after that. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Plasma concentration of Nitric oxide. Timepoint: Before drug prescription and on days 30 and 60 after that. Method of measurement: ELISA kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before drugs prescription and every week after that. Method of measurement: Visual Analogue Scale (VAS).</sec_outcome>
      <sec_outcome>َAdverse drug reactions. Timepoint: Every day. Method of measurement: Interview with patients and their reports.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Sobhan Pharmaceutical Factory</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The vice chancellor for research affairs of Shahid Beheshti University of Medical Sciences</source_name>
      <source_name>Sobhan Pharmaceutical Factory</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-26</approval_date>
        <contact_name>School of Medicine Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar Avenue, Daneshjoo Blvd, Velenjak, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
