<?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>IRCT20091111002695N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of anti lophomonas parasite treatment on patients chronic cough well-being</public_title>
      <acronym></acronym>
      <scientific_title>Effect of anti lophomonas parasite treatment on patients chronic cough well-being</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52654</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done by Randomizer website ( www.randomizer.org), Blinding description: All the drugs will be prepared with united shape, color and packages. the only difference is the code on the package. The drugs will be given to our colleague who is present in the clinic everyday and is blinded to the types of the drugs and groups of treatment. Each time the patients refer to our clinic they will receive the same drug based on their randomized code.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: chronic cough. Condition 2: Lophomonas Blattarum.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Tinidazole 500mg in form of tablet, one each 12 hours, for14 days. The Active Pharmaceutical Ingredient is provided by Pars daru Pharmaceutical company. Intervention 2: Control group: Placebo in form of tablet B1 300 mg from Jalinus Pharmaceutical company ,one each 12 hours, for 14 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
treat with Tinidazole( before and after treatment), cough garding( before and after treatment),sputum and its color ( before and after treatment), dyspnea and its grading( before and after treatment), temperature ( before and after treatment), Lophomonas existing in smear or BAL( before and after treatment), Inf cells grading in sputum and BAL( before and after treatment), Sex and age

When:
One Month after publishing the results.

To whom:
There will be no limitation for accessing the data.

Conditions:
There will be no limitation for accessing the data. If someone need to use the data, he/she might ask the corresponding author for permission.

Where to obtain:
Contact the corresponding author.

How to obtain:
After contacting the corresponding author via phone or Email, the data will be provided.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Mirsadraee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187147578</zip>
        <telephone>+98 51 3870 4347</telephone>
        <email>majidmirsadraee@mshdiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Mirsadraee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 80, 15th Kosar, Kosar Ave., Vakilabad Blv</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187147578</zip>
        <telephone>+98 51 3870 4347</telephone>
        <email>majidmirsadraee@mshdiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients suffering from more than one months cough who could not be controlled by past medical treatments
patients with normal physical examination
patients with normal chest-x-ray</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>drug allergy
proven asthma
Tuberculosis(TB), gastroesophageal reflux(GERD) , ear wax, Chronic Obstructive Pulmonary disease(COPD), Carcinoma,hemoptesis
Angiotensin converting enzyme inhibitors(ACEI) users</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R05</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cough</hc_keyword>
      <hc_keyword></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>Intervention group:Tinidazole 500mg in form of tablet, one each 12 hours, for14 days. The Active Pharmaceutical Ingredient is provided by Pars daru Pharmaceutical company</i_keyword>
      <i_keyword>Control group: Placebo in form of tablet B1 300 mg from Jalinus Pharmaceutical company ,one each 12 hours, for 14 days .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lophomonas Blattarum being in smear or Bronchoalveolarlavage. Timepoint: Before intervention and 14 days after intervention. Method of measurement: Trichrome staining.</prim_outcome>
      <prim_outcome>Chronic cough grading. Timepoint: Before intervention and 14 days after intervention. Method of measurement: Global Initiative for Asthma (GINA) guideline.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dyspnea. Timepoint: Before intervention and 14days after intervention. Method of measurement: physical examination.</sec_outcome>
      <sec_outcome>Sputum inflammatory cells. Timepoint: Before intervention and 14days after intervention. Method of measurement: sputum cytology.</sec_outcome>
      <sec_outcome>Dyspnea garding. Timepoint: Before intervention and 14 days after intervention. Method of measurement: GINA(global strategy for asthma).</sec_outcome>
      <sec_outcome>Body temperature. Timepoint: Before intervention and 14days after intervention. Method of measurement: Thermometer.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-30</approval_date>
        <contact_name>Ethics committee of Islamic Azad University- Mashhad branch</contact_name>
        <contact_address>Shahin Far Building, sarab alley, Azadi street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
