<?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>IRCT20190921044827N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-06</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Ostokhodus Alavi capsule on students concentration.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of an Iranian traditional medicine product (Ostokhodus Alavi capsule) on the cognitive performance of adolescent female students in Yazd city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42682</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The drugs and placeboes are labeled by unique randomly-generated codes consisting of two alphabetic letters and one number. During the study, the participants are given medications, according to the order of their arrival and randomization sheets (containing only anonymous codes), Blinding description: The Ostokhodus Alavi and placebo capsules were coded. The participants, researchers, and analyzers were blind. Only the pharmaceutical company is aware of the association between the codes and capsules.</study_design>
      <phase>3</phase>
      <hc_freetext>cognitive function.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Ostokhodus Alavi capsule, Contents: avandula spp., Anacyclus pyrethrum, Polypodium vulgare, Cuscuta spp, Paeonia officinalis, Vitis vinifera, honey, Dose: a 250 mg capsule after breakfast for 6 weeks, Company: Tuba pharmaceutical company. Intervention 2: Control group: Placebo capsule, Contents: avicel (Microcrystalline cellulose) , Dose: a 250 mg capsule after breakfast for 6 weeks, Company: Tuba pharmaceutical company.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Publishing the number and age of participants and clinical trial results before and after intervention which consist of cognitive function indicators and the level of sputum cortisol after making the data unidentifiable in the form of a Ph.D. thesis and an article indexing in ISI

When:
after PhD thesis defence

To whom:
researchers from academia and research institutes

Conditions:
research studies

Where to obtain:
Sending Email to the researcher, Samane Tefagh, at the email address: s.tefagh@sbmu.ac.ir

How to obtain:
After receiving the applicant's email, the requested data will be sent back to the same email address within two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samane Tefagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shams alley, across Tvanir, Vali-e-asr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516745811</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>s.tefagh@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samane Tefagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali e asr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998856349</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>s.tefagh@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy 16 to 17 years old girls
acknowledgment of parents and students</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>17 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosed with sever depression or anxiety or stress
Diagnosed with psychological disorders that interfere with cognition function
Low IQ(Low grade in mathematics, science and literature courses)
Consumption of herbal or chemical drugs on cognition function at the beginning of the study
Sever hearing or movement impairment that interfere with passing the PASAT study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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:Ostokhodus Alavi capsule, Contents: avandula spp., Anacyclus pyrethrum, Polypodium vulgare, Cuscuta spp, Paeonia officinalis, Vitis vinifera, honey, Dose: a 250 mg capsule after breakfast for 6 weeks, Company: Tuba pharmaceutical company</i_keyword>
      <i_keyword>Control group: Placebo capsule, Contents: avicel (Microcrystalline cellulose) , Dose: a 250 mg capsule after breakfast for 6 weeks, Company: Tuba pharmaceutical company</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental health. Timepoint: Beginning of the study, 3 weeks, 6 weeks and 10 weeks from the beginning of the study. Method of measurement: Paced Auditory serial addition Test(PASAT).</prim_outcome>
      <prim_outcome>Average respond time. Timepoint: Beginning of the study, 3 weeks, 6 weeks and 10 weeks from the beginning of the study. Method of measurement: PASAT test.</prim_outcome>
      <prim_outcome>Sustained attention. Timepoint: Beginning of the study, 3 weeks, 6 weeks and 10 weeks from the beginning of the study. Method of measurement: PASAT test.</prim_outcome>
      <prim_outcome>Mental fatigue. Timepoint: Beginning of the study, 3 weeks, 6 weeks and 10 weeks from the beginning of the study. Method of measurement: PASAT test.</prim_outcome>
      <prim_outcome>Sputum cortisol level. Timepoint: Beginning of the study, 6 weeks and 10 weeks from the beginning of the study. Method of measurement: ELISA Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Tuba pharmaceutical company</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
      <source_name>Tuba pharmaceutical company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-26</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciencess, Yaman street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
