<?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>IRCT20220506054749N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-08</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of hydroalcoholic extract of Nasturtium officinale on quality of life in asthmatic patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of hydroalcoholic extract of Nasturtium officinale on quality of life in asthmatic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63551</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the Restricted randomization method of the randomization Random allocation rule method. For this purpose, first determine a total sample size, then randomly assign a set of them to the intervention group and the rest to the control group. 30 balls for the intervention group and 30 balls for the control group are placed in a lottery container and then the balls are randomly removed from the container without replacement and the created sequence is recorded, Blinding description: Capsules are individually packed envelopes and have an identification number. Capsules and envelopes of Nasturtium officinale extract and placebo are offered in exactly the same appearance and packaging, which will blind the participants and the researcher.</study_design>
      <phase>3</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Watercress was collected from Shahniz (Margon) region of Kohgiluyeh and Boyer-Ahmad provinces in the summer of 1399. After collecting watercress, 100 grams of plant powder is soaked in 500 ml of ethanol and placed at room temperature for 48 hours. The extract is then filtered and the rest is extracted again with solvent after 24 hours and added to the original extract. The solvent is then evaporated at a temperature of 40 ° C by a rotary refrigerator and incubated at a temperature of 37 ° C to dry extract and stored in the refrigerator at a temperature of 4 ° C for further experiments. To the group of hydroalcoholic extract of watercress in the amount of 500 mg twice a day for 4 weeks. Blood samples and all questionnaires (including ACT test, quality of life and sleep disorders) are completed at the beginning and end of the study by research units. Blood samples are taken from the Clot and CBC tubes. To measure the number of blood eosinophils, a CBC test is performed with a Cismax device. The serum sample is also elucidated and stored at minus -70 ° C. IgE levels are then measured. Intervention 2: Control group: Flour and capsules were prepared and placed in 500 mg capsules in jars of the same shape and size as the main medicine and packaged (of course in the university without my presence) and the patient was explained in person that twice a day. Consume for 28 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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Reza Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahari Boulevard</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>:33346070-074</telephone>
        <email>amirhosseindoustimotlagh@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Abbasi Reza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahari Boulevard</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3334 6070</telephone>
        <email>amirhosseindoustimotlagh@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both sexes
age 18-65 years
Asthma diagnosis based on the Global Initiative for Asthma (GINA)
Asthma symptoms not fully controlled based on ACT (Asthma Control Test) score from 5 to24
No severe asthma exacerbation in the last four weeks
Complete conscious satisfaction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>smoking history
pregnant women
taking any preparation containing NOE</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asthma</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:Watercress was collected from Shahniz (Margon) region of Kohgiluyeh and Boyer-Ahmad provinces in the summer of 1399. After collecting watercress, 100 grams of plant powder is soaked in 500 ml of ethanol and placed at room temperature for 48 hours. The extract is then filtered and the rest is extracted again with solvent after 24 hours and added to the original extract. The solvent is then evaporated at a temperature of 40 ° C by a rotary refrigerator and incubated at a temperature of 37 ° C to dry extract and stored in the refrigerator at a temperature of 4 ° C for further experiments. To the group of hydroalcoholic extract of watercress in the amount of 500 mg twice a day for 4 weeks. Blood samples and all questionnaires (including ACT test, quality of life and sleep disorders) are completed at the beginning and end of the study by research units. Blood samples are taken from the Clot and CBC tubes. To measure the number of blood eosinophils, a CBC test is performed with a Cismax device. The serum sample is also elucidated and stored at minus -70 ° C. IgE levels are then measured.</i_keyword>
      <i_keyword>Control group: Flour and capsules were prepared and placed in 500 mg capsules in jars of the same shape and size as the main medicine and packaged (of course in the university without my presence) and the patient was explained in person that twice a day. Consume for 28 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Asthema Control Test score. Timepoint: Before intervention - 28 days after intervention. Method of measurement: ACT test questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Before intervention - 28 days after intervention. Method of measurement: Quality of Life Questionnaire (SF-12).</sec_outcome>
      <sec_outcome>Quality of sleep. Timepoint: Before intervention - 28 days after intervention. Method of measurement: Petersburg Sleep Quality Questionnaire (PSQI).</sec_outcome>
      <sec_outcome>Number of eosinophils. Timepoint: Before intervention - 28 days after intervention. Method of measurement: Cismax device.</sec_outcome>
      <sec_outcome>Immunoglobulin E. Timepoint: Before intervention - 28 days after intervention. Method of measurement: Spectrophotometry.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-24</approval_date>
        <contact_name>Ethics Committee of Yasouj University of Medical Sciences</contact_name>
        <contact_address>Motahari Boulevard Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
