<?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>IRCT20230318057752N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-31</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of caffeine on cognitive and motor responses</public_title>
      <acronym></acronym>
      <scientific_title>Effects of brushing with caffeinated toothpaste on cognitive and motor responses of the central nervous system: A pilot study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71213</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization of people is done based on the permutation of five random blocks, and the random sequence based on this method will be done by lottery using a table of random numbers, Blinding description: Blocking and allocation sequence for concealment will be done by a person not involved in the research. The shape and packaging of the capsules and toothpaste will be the same so that the researchers and participants will not be aware of the package (one capsule and one toothpaste) of each person. Only the person responsible for packaging the drugs will know the numbers of the respective envelopes, and none of the researchers or participants will know the contents of the package that each person receives. Packages will be placed in A, B, C, D and E envelopes by a person as a coder. Patients will not be aware of the assignment of codes to package envelopes, and the researchers who will provide the packages to the people at the place of implementation of the plan will not be aware of the contents of the packages and the allocation of people to five groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Cognitive and motor responses of the central nervous system.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group receiving placebo capsule and toothbrush with 100mg caffeinated toothpaste for 2 minutes. Intervention 2: Intervention group: The group receiving placebo capsule and toothbrush with 100mg caffeinated toothpaste for 3 minutes. Intervention 3: Intervention group: The group receiving placebo capsule and toothbrush with 100mg caffeinated toothpaste for 4 minutes. Intervention 4: Control group: The group receiving 100mg caffeine capsule and toothbrush with regular toothpaste for 2 minutes. Intervention 5: Control group: The group receiving placebo capsule and toothbrush with normal toothpaste for 2 minutes.</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:
Demographic information and clinical trial results

When:
3 months after the publication of the article, it will be possible to access the data.

To whom:
Researchers in all universities of medical sciences

Conditions:
Researchers can submit their request to the Vice-Chancellor of Research and Technology and the Ethics Committee of Fasa University of Medical Sciences, and if they agree, the data will be provided to them.

Where to obtain:
Fasa University of Medical Sciences, Vice President of Research and Technology

How to obtain:
Approval of the Research and Technology Vice-Chancellor and Ethics Committee of Fasa University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kiarash Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina square, Fasa</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۴۶۱۶۸۶۶۸۸</zip>
        <telephone>+98 71 5335 0994</telephone>
        <email>kiarashzare1998@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Goharinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina square, Fasa</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۴۶۱۶۸۶۶۸۸</zip>
        <telephone>0715335099</telephone>
        <email>goharinia@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy people with informed consent to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any reaction or sensitivity to caffeine
Addicted to drugs, alcohol and tobacco
Consuming coffee and painkillers containing caffeine, nerve agents, tea and drinks that can affect the tests, from 48 hours before
Cognitive disorders
Mental disorders
Cardiovascular diseases
Neurological disorders
Thyroid disorders
Mouth or mucous membrane diseases</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The group receiving placebo capsule and toothbrush with 100mg caffeinated toothpaste for 2 minutes</i_keyword>
      <i_keyword>Intervention group: The group receiving placebo capsule and toothbrush with 100mg caffeinated toothpaste for 3 minutes</i_keyword>
      <i_keyword>Intervention group: The group receiving placebo capsule and toothbrush with 100mg caffeinated toothpaste for 4 minutes</i_keyword>
      <i_keyword>Control group: The group receiving 100mg caffeine capsule and toothbrush with regular toothpaste for 2 minutes</i_keyword>
      <i_keyword>Control group: The group receiving placebo capsule and toothbrush with normal toothpaste for 2 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Selective attention capacity. Timepoint: Before receiving caffeine, 10, 30 and 60 minutes after receiving caffeine. Method of measurement: Using computer tests.</prim_outcome>
      <prim_outcome>Selective processing speed. Timepoint: Before receiving caffeine, 10, 30 and 60 minutes after receiving caffeine. Method of measurement: Using computer tests.</prim_outcome>
      <prim_outcome>Short-Term Memory. Timepoint: Before receiving caffeine, 10, 30 and 60 minutes after receiving caffeine. Method of measurement: Using computer tests.</prim_outcome>
      <prim_outcome>Hand Eye Coordination. Timepoint: Before receiving caffeine, 10, 30 and 60 minutes after receiving caffeine. Method of measurement: Using computer tests.</prim_outcome>
      <prim_outcome>Serum caffeine level. Timepoint: 10, 30 and 60 minutes after receiving caffeine. Method of measurement: ELISA.</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>Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-25</approval_date>
        <contact_name>Ethics Committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Ibn Sina square, Fasa Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
