<?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>IRCT20200205046384N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-09</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>investigating the effect of pomegranate extract in asthma</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating  the effect of pomegranate extract on  some serum immunologic factors(IL-35، hs-CRP), oxidative stress status (PAB) and spirometry test in patients with persistent allergic asthma with mild and moderate severity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45612</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be randomized through the statistical method of permuted block. Blocks will be determined using statistical software, Blinding description: The researcher and participants are blinded by coding the drug in the form of A and B, so that someone else is asked to encode the pomegranate extracts and placebo to A and B which are similar in appearance. The participants and the researcher will be uninformed of the type of intervention. As a result, the study will be performed in the forms of double blind.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group receiving  pomegranate extract 500 mg / day in capsule form (two 250 mg capsules daily). Drug production center: The institute of medicinal plants research  of Jahad Daneshgahi. The duration of drug use is 8 weeks. Intervention 2: Control group: Placebo-receiving group: Two capsules daily containing 250 mg toasted flour . Drug Production Center: The institute of medicinal plants research of Jahad Daneshgahi. The duration of drug use is 8 weeks.</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>Zainab Shateri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department,Faculty of Paramedicine, Ahvaz Jondishapour University of Medical Sciences, Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>0098613311</telephone>
        <email>shateri.z@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zainab Shateri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6137515794</zip>
        <telephone>0098613311</telephone>
        <email>shateri.z@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ages 18 to 65 years
Patients with mild to moderate persistent allergic asthma, Forced Expiratory Volume in First Second(FEV1) greater than 60%
Body mass index(BMI):18.5-30
Both sexes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>smoking
Diabetes
Pregnancy and lactation
Autoimmune diseases
Malignancies
Digestive, liver or kidney problems
Pneumonia
Other pulmonary diseases
Antioxidant usage
blood pressure-lowering drugs  (Statin and ACE Inhibitors)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>آسم</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: group receiving  pomegranate extract 500 mg / day in capsule form (two 250 mg capsules daily). Drug production center: The institute of medicinal plants research  of Jahad Daneshgahi. The duration of drug use is 8 weeks.</i_keyword>
      <i_keyword>Control group: Placebo-receiving group: Two capsules daily containing 250 mg toasted flour . Drug Production Center: The institute of medicinal plants research of Jahad Daneshgahi. The duration of drug use is 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Prooxidant-antioxidant balance. Timepoint: at the beginning of the study and 8 weeks after the intervention. Method of measurement: Based on blood test using calorimetry.</prim_outcome>
      <prim_outcome>Forced Vital Capacity(FVC)/Forced Expiratory Volume in First Second(FEV1)، FEV1، FVC. Timepoint: at the beginning of the study and 8 weeks after the intervention. Method of measurement: Based on the result of the spirometer- Variable scale: percent.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>High sensitivity C-reactive protein (hsCRP). Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Laboratory measurement (quantitative luminescence) - mg / dl.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Based on the results of the Easy Life aneroid Sphygmomanometer-mmHg.</sec_outcome>
      <sec_outcome>Clinical variables and general patient status. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Based on a questionnaire filled by a specialist physician.</sec_outcome>
      <sec_outcome>IL-35. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Based on laboratory measurements-pg/ml.</sec_outcome>
      <sec_outcome>Complete blood cell count and differential count. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Based on laboratory measurement.</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>2020-02-21</approval_date>
        <contact_name>Research Ethics Committee of Ahvaz Jondishapour University of Medical Sciences</contact_name>
        <contact_address>Nutrition dep, faculty of Paramedicine, Ahvaz Jondishapour University of Medical Sciences, Golestan Highway, Ahvaz Town Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
