<?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>IRCT201103034737N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-03-20</date_registration>
      <primary_sponsor>Mohammad Ali Raeessi + Baqiyatallah University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>A comparison of the therapeutic effect of "systemic steroid" and "honey plus coffee" on persistent postinfectious cough</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of the therapeutic effect of "systemic steroid" and "honey plus coffee" on persistent postinfectious cough</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5071</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>persistent post infectious cough (PPC).</hc_freetext>
      <i_freetext>Intervention 1: Prednisolone: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of "320 mg prednisolone" is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week. Intervention 2: Coffee: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of "70 grams of original instnt Coffee" is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week. Intervention 3: Honey: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of 500 grams of Honey) is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week. Intervention 4: Coffee and Honey: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of 70 grams of original instant Coffee as well as 500 grams of Honey) is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week. Intervention 5: Placebo: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of Placebo) is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.</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>Mohammad Ali Raeessi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No: 117, Mollasadra residental complex, Kharazmi  St,  Mollasadra Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435913118</zip>
        <telephone>+98 21 8803 0514</telephone>
        <email>raeessi_ma@yahoo.com    raeessi@bmsu.ac.ir</email>
        <affiliation>Baqiyatallah University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Raeessi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No: 117, Molasadra residental complex, Kharazmi St., Mollasadra Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435913118</zip>
        <telephone>+98 21 8803 0514</telephone>
        <email>raeessi_ma@yahoo.com ---   raeessi@bmsu.ac.ir</email>
        <affiliation>Baqiyatallah University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: PPC for more than three weeks of duration, normal routine laboratory tests, no systemic disease, normal chest X-Ray, age between 21 and 65 years&#13;
Exclusion criteria: presence of any systemic disease, other causes of chronic cough</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J31.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic pharyngitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Prednisolone: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of "320 mg prednisolone" is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.</i_keyword>
      <i_keyword>Coffee: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of "70 grams of original instnt Coffee" is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.</i_keyword>
      <i_keyword>Honey: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of 500 grams of Honey) is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.</i_keyword>
      <i_keyword>Coffee and Honey: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of 70 grams of original instant Coffee as well as 500 grams of Honey) is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.</i_keyword>
      <i_keyword>Placebo: 25 grams of the jam-like paste &#13;
(Each 600 grams of the product consisted of Placebo) is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Persistent postinfectious cough (PPC). Timepoint: before and after the treatment. Method of measurement: frequency of cough: low (+), moderate (++), and high (+++).</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>Mohammad Ali Raeessi + Baqiyatallah University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethic Committee in Medical Sciences Research, Deputy of Research and Technology, Baqiyatallah Univer</contact_name>
        <contact_address>Sheikhbahaee St., Mollasadra Ave Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
