<?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>IRCT2016020826447N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-12</date_registration>
      <primary_sponsor>Student's Scientific Research Center of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Clonidine and Dextromethorphan on cold pain threshold</public_title>
      <acronym></acronym>
      <scientific_title>Assessment the effect of Clonidine and Dextromethorphan on cold pain threshold in healthy volunteers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Other</recruitment_status>
      <url>https://irct.ir/trial/21924</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>The pain induced by cold.</hc_freetext>
      <i_freetext>All the participants will take Clonidine and Dextromethorphan and Placebo tablets (Considering a 10 day wash-out period for each dose of medication).&#13;
 Clonidine tablet, 0.2 mg single dose, once during the test, 1.5 hours before test. &#13;
Dextromethorphan tablet, 0.3 mg/kg single dose, once during the test, 30 minutes before test. &#13;
Placebo, once during test, 1 hours before test. &#13;
Clonidine tablet, 0.2 mg single dose with Dextrometorphan tablet, 0.3 mg /kg single dose, once during test, 1 hours before test..</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>Porooshat Nazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, the corner of  Qods St, Keshvarz Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 910 988 3401</telephone>
        <email>p-nazemi@student.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Amirhossein Orandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini hospital, end of Keshavarz Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2828</telephone>
        <email>horandi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Complete physical and mental health; Informed consent to participate in the study; 18-45 years of age; No cigarette smoking and coffee use; No history of taking anti depressant and analgesic medications. Exclusion Criteria: Acute or chronic pain; Pregnancy; Gastrointestinal bleeding; Renal or liver disease; Asthma; Diabetes; Hyper tension; Mental and, or neurological disease; Hyper sensitivity to Clonidine and Dextromethorphan.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T33.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Superficial frostbite of wrist and hand</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All the participants will take Clonidine and Dextromethorphan and Placebo tablets (Considering a 10 day wash-out period for each dose of medication).&#13;
 Clonidine tablet, 0.2 mg single dose, once during the test, 1.5 hours before test. &#13;
Dextromethorphan tablet, 0.3 mg/kg single dose, once during the test, 30 minutes before test. &#13;
Placebo, once during test, 1 hours before test. &#13;
Clonidine tablet, 0.2 mg single dose with Dextrometorphan tablet, 0.3 mg /kg single dose, once during test, 1 hours before test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cold pain threshold. Timepoint: Before interventions, First day(After taking pills available in packet No.1), 11th day(after taking pills available in packet No.2), 21th day(After taking pills available in packet No.3), 31th day(After taking pills available in packet No.4), 41th day(After taking pills available in packet No.5). Method of measurement: The maximum storage time (in minutes) in a mixture of water and ice.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Dr.Amirhossein Orandi</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Student's Scientific Research Center of Tehran University of Medical Sciences</source_name>
      <source_name>Dr.Amirhossein Orandi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-02</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, the corner of Qods St, Keshvarz Blvd, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
