<?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>IRCT20170809035599N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-19</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Cordia Myxa,s herbal syrup on the Treatment of Dry Coughing</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Cordia Myxa,s herbal syrup and Diphenhydramine in the treatment of dry cough</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29775</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, both Diphenhydramine and Cordia Myxa,s herbal syrup are packed in the same boxes. Different serial numbers are placed on the boxes where the medications can be separated. We use simple randomization model using random number table (computer randomization method). The advantages of this kind of randomization are that the type of treatment allocated to the two groups is totally unpredictable and, according to the theory of probabilities, it can be guaranteed that in a large number, the sample size of the study will be similar in the intervention and control groups. It should be noted, that the implementation of this method is very simple. Since we have a complete list of elements that constitute the population, we use individual sampling. In this research, we use a randomized numbers table as randomization method, which is a computational method for generating a sequence of numbers that do not have a specific pattern. A random number is a mode of possible state that is selected during a random event. This method starts with a random initial number (core). Then we put this number into power 2 and select its middle numbers. The number of selected numbers is equal to the number of core digits. Then, after putting the zero point at the beginning of the generated middle number, the random number is obtained and according to the specific mathematical algorithm, the sequence numbers are generated. Any number is independent from other numbers, Blinding description: the researcher and the volunteer participate in this study are completely unaware of the final stage of extracting the final information from the drugs that are presented separately by the pharmacist which are identical in appearance were placed in identical bottles.</study_design>
      <phase>3</phase>
      <hc_freetext>dry cough.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The recipients of Cordia Myxa,s herbal syrup (62 patients)Cordia Myxa,s herbal syrup produced in pharmaceutical technology incubator of Ahvaz jundishapur University of medical sciences. Dosage: 5mg/kg/day in 4 divided doses (orally). Survey: after 72 hours from initial intervention, the number and severity of patients night and day cough will check. Intervention 2: Control group: The recipients of Diphenhydramine syrup (62 patients)Diphenhydramine syrup produced in Alborz Darou Pharmaceuticals Company.Dosage: 5mg/kg/day in 4 divided doses (orally).Survey: after 72 hours from initial intervention, the number and severity of patients night and day cough will check.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amanollah Zarei Ahmady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6185676789</zip>
        <telephone>+98 61 3336 1969</telephone>
        <email>amanazarei@ymail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amanollah Zarei Ahmady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3373 8382</telephone>
        <email>amanzarei@ymail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 6-12 years who referred to the clinic with the main complaint of acute cough and without foreign body aspiration on the first or second day of coughing.
The associated symptoms include upper respiratory tract infections, mild fever (oral temperature 37.8-38.3), rhinorrhea, sneezing, mild sore throat, mild headache, Mild nasal congestion, hoarse voice, conjunctivitis.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Symptoms of bacterial infection of the upper respiratory tract: middle to sever fever, severe sore throat with ingestion, nausea, vomiting, abdominal pain and severe headache.
The presence of symptoms of lower respiratory tract infection: high fever, cough, dyspnea, boredom, chest pain and tachypnea pain.
The presence of symptoms of airway reactions including wheezing, tachypnea, dyspnea.
Signs of allergy such as the presence of symptoms of nose and eye itching, or a history of repetitions of similar symptoms and outer body spiration.
Avoid taking medication before referral
Start the symptoms of otitis or sinusitis.
Start symptoms of low respiratory involvement.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cough</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: The recipients of Cordia Myxa,s herbal syrup (62 patients)Cordia Myxa,s herbal syrup produced in pharmaceutical technology incubator of Ahvaz jundishapur University of medical sciences. Dosage: 5mg/kg/day in 4 divided doses (orally). Survey: after 72 hours from initial intervention, the number and severity of patients night and day cough will check.</i_keyword>
      <i_keyword>Control group: The recipients of Diphenhydramine syrup (62 patients)Diphenhydramine syrup produced in Alborz Darou Pharmaceuticals Company.Dosage: 5mg/kg/day in 4 divided doses (orally).Survey: after 72 hours from initial intervention, the number and severity of patients night and day cough will check.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cough. Timepoint: One day before the intervention and three days after the intervention began. Method of measurement: The number and severity of patients' night and day coughing.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-16</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Golestan Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
