<?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>IRCT20090808002306N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-29</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of herbal anti-asthma product along with standard treatment on the intervals and severity of moderate chronic asthma attacks in children and adolescents 6 to 18 years</public_title>
      <acronym></acronym>
      <scientific_title>Clinical study of the effect of oral products of three plants: licorice (Glycyrrhiza glabra), fragrant violet (Viola adorata) and tarpaulin (Operculina turpethum) as an add-on on the intervals and severity of moderate chronic asthma attacks in children and adolescents 6 to 18 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53295</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In the design of this study, patients were divided into two categories based on the odd and even national code receiving the main drug (odd national code) and control (even national code). The first group receives anti-asthma drugs and the second group receives placebo that is exactly the same with the main drug; And one month after taking the drug, evaluations are done, Blinding description: In this study, the pulmonologist and patients are not aware of the type of drug received (main drug or placebo). The drug and the placebo are exactly the same and are distinguished only by a small code that only the researcher and responsible for data collection (student) know about.</study_design>
      <phase>2-3</phase>
      <hc_freetext>moderate persistent asthma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, subjects in the case group received 4 packs of 30 anti-asthma pills (containing components: asparagine, hydroxycinnamic acids, glycyrrhizin, salicylic acid, methyl ester, betanitropropionic acid, poline, cycloviolasin, saponins, flavonoids, alkaloids of three plants turbid, aromatic violet and licorice) are delivered. The recipe is two morning pills and two night pills. This herbal compound is produced by Sinafaravar Pharmaceutical Company located in Najafabad, Isfahan. Intervention 2: Control group: The placebo is exactly the same as the main drug produced by Sinafaravar Pharmaceutical Company and is given to the control group for one month with the same prescription.</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 need to do this.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Mohammad Sabzghabaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences and Health Services, Hezar Jerib St. , Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 7070</telephone>
        <email>sabzghaba@pharm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Mohammad Sabzghabaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7070</telephone>
        <email>sabzghaba@pharm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients between 6 and 18 years old with chronic asthma in children and adolescents with moderate severity according to the Nelson Pediatrics textbook published in 2018 (page 202)
Do not use other drugs at the same time and outside the official treatment protocol that is effective on the disease.
No possible history of underlying cardiovascular, renal, hepatic and biliary tract diseases</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Moderate persistent asthma</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: In this study, subjects in the case group received 4 packs of 30 anti-asthma pills (containing components: asparagine, hydroxycinnamic acids, glycyrrhizin, salicylic acid, methyl ester, betanitropropionic acid, poline, cycloviolasin, saponins, flavonoids, alkaloids of three plants turbid, aromatic violet and licorice) are delivered. The recipe is two morning pills and two night pills. This herbal compound is produced by Sinafaravar Pharmaceutical Company located in Najafabad, Isfahan.</i_keyword>
      <i_keyword>Control group: The placebo is exactly the same as the main drug produced by Sinafaravar Pharmaceutical Company and is given to the control group for one month with the same prescription.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spiro metric Respiratory Test Index (FEV1). Timepoint: Spirometry tests are taken from patients before the start of the study and the test is performed again one month after taking the drug. Method of measurement: Pulmonary indices are recorded by spirometry.</prim_outcome>
      <prim_outcome>Spiro metric Respiratory Test Index (FVC). Timepoint: Spirometry tests are taken from patients before the start of the study and the test is performed again one month after taking the drug. Method of measurement: Pulmonary indices are recorded by spirometry.</prim_outcome>
      <prim_outcome>Spiro metric Respiratory Test Index (FEV1/FVC). Timepoint: Spirometry tests are taken from patients before the start of the study and the test is performed again one month after taking the drug. Method of measurement: Pulmonary indices are recorded by spirometry.</prim_outcome>
      <prim_outcome>Number of cough attacks per day or week. Timepoint: Before the study and one month after taking the drug. Method of measurement: By asking parents and registering on the data collection form.</prim_outcome>
      <prim_outcome>Number of puffs used salbutamol spray per day. Timepoint: Before the study and one month after taking the drug. Method of measurement: By asking parents and registering on the data collection form.</prim_outcome>
      <prim_outcome>Severe restrictions on exercise or activity. Timepoint: Before the study and one month after taking the drug. Method of measurement: By asking parents and registering on the data collection form.</prim_outcome>
      <prim_outcome>Evaluation of quality of life and asthma control in children and adolescents. Timepoint: Before the study and one month after taking the drug. Method of measurement: Using two asthma control questionnaires completed by parents and children or adolescents.</prim_outcome>
      <prim_outcome>Number of shortness of breath per day or week. Timepoint: Before the study and one month after taking the drug. Method of measurement: By asking parents and registering on the data collection form.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-12</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellery for research, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
