<?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>IRCT20200105046009N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-12</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>effect of plantago major on severity of cought</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of  Plantago major syrup on severity of cough in acute bronchitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44759</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Drugs in two categories (drug and placebo) are made by Sanabel Daru Co. and sent to the statistician. Randomization is done using permuted blocks randomization.  The size of the blocks is considered 4. All possible combinations are determined from a sequence of 4 of the two drugs (6 combinations), and then their sequence is determined using a table of random numbers.
The statistician encodes them and gives them to the researcher blind. Unlock codes will be done after the end of the study. 
In case of side effects, the drug code will be unlocked, Blinding description: Placebo syrup and medicine will be prepared in the same form, label, taste, and odor,  by the Sanabel DaruCo. The only one who knows the identity of the syrups is the biostatistician of the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Brunchit.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Plantago major syrup containing extract of the seed of Plantago major, made by Sanabel Daru Company is used. Syrups are given to the patient on a weekly basis in 300 cc pets. The patient takes 30 ccs orally (10 ccs three times every 8 hours) daily for 10 days. Intervention 2: Control group:  Placebo syrups with the same taste,  color, smell, shape and label of the Plantago major syrup will be made by Sanabel Daru Company. Syrups are given to the patient on a weekly basis in 300 cc pets. The patient takes 30 cc orally (10 cc in three times, every 8 hours) daily for 10 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Ali Mozaffarpur</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol. Ganj afrooz. Babol university of Medical Science. School of Persian Medicine</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4718647745</zip>
        <telephone>+98 11 3219 4728</telephone>
        <email>seyyedali1357@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Ali Mozaffarpur</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganjafrooz st., Babol university of Medical Science</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4718647745</zip>
        <telephone>+98 11 3219 4728</telephone>
        <email>seyyedali1357@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 20 t0 75 years old
acute cough
clinical diagnosis of acute bronchitis</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant or lactating women
Patients who took a cough and sputum medication for one week before the study
History of respiratory disease such as chronic bronchitis, bronchiectasis, asthma-pneumonia, cystic fibrosis, lung cancers or active pulmonary tuberculosis
Kidney or liver failure
Genetic diseases such as galactose intolerance or lactose intolerance
History or presence of cardiovascular disease, neurological disease, metabolic disease or mental disorders. Hematologic disease or malignant tumor (unless recurrent within 5 years)
A history of alcohol or substance abuse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute bronchiolitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Plantago major syrup containing extract of the seed of Plantago major, made by Sanabel Daru Company is used. Syrups are given to the patient on a weekly basis in 300 cc pets. The patient takes 30 ccs orally (10 ccs three times every 8 hours) daily for 10 days.</i_keyword>
      <i_keyword>Control group:  Placebo syrups with the same taste,  color, smell, shape and label of the Plantago major syrup will be made by Sanabel Daru Company. Syrups are given to the patient on a weekly basis in 300 cc pets. The patient takes 30 cc orally (10 cc in three times, every 8 hours) daily for 10 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of acute bronchitis. Timepoint: Assessing patients at the first visit (before starting the study), on the fifth day and on the tenth day after starting treatment. Method of measurement: Bronchitis Severity Score (BSS) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life for acute cough. Timepoint: Before starting treatment, after the end of treatment. Method of measurement: Standard Quality of Life Questionnaire for Acute Cough (Leicester Cough Questionnaire).</sec_outcome>
      <sec_outcome>Severity of cough. Timepoint: Assessing patients at the first visit (before starting the study), on the fifth day and on the tenth day after starting treatment. Method of measurement: cough evaluating questionnaire based on Visual Analog Scales.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-19</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Babol, Sargor Ghasemi avenue, Babol University of Medical science Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
