<?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>IRCT20141125020082N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-07</date_registration>
      <primary_sponsor>Iranshahr University of Medical Sciences</primary_sponsor>
      <public_title>1-	The effect of salvia officinalis tea on the sleep quality of Students Living in Dormitories of Iranshahr University of Medical Sciences, 2021.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Salvia Officinalis tea on the sleep quality of Students Living in Dormitories</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59723</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Among the six student dormitories at Iranshahr University of Medical Sciences, students with sleep quality disorders are identified through a pre-test and then given a code to the rooms where students with sleep disorders meet the inclusion criteria and consent to participate in the study. To be. Using the random numbers software version CF-1.7.1, the rooms where students live are divided into two groups of test and control (it is possible to use roommates from each other), Blinding description: Boxes and bags of tea will not differ in appearance, tea boxes are numbered by a third party who knows the contents at the bottom. The researcher then delivers boxes of the same number to the students in a room. In addition, researchers and participants will not have information about the main drink and placebo.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sleep Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group brews ten grams of sage and receives it every night, before going to bed for a month. Intervention 2: Control group:Control group: This group of placebo, which is brown sugar in the amount of ten grams, is inhaled and received every night before going to bed.</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:
Some demographic information such as age, sex, marital status, household income, and information about students' sleep disorders will be published in the form of an article without identifying the participants.

When:
2022-2023

To whom:
Researchers in the field of medical sciences

Conditions:
By referring to the archive of medical science journals

Where to obtain:
By sending an email to the responsible author, Masoome Shahnavazi: mshanavazi1392@gmail.com

How to obtain:
By sending an email to the responsible author, Masoome Shahnavazi: mshanavazi1392@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoome Shahnavazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranshahr, Baluch Blvd., Vice Chancellor for Education, Iranshahr University of Medical Sciences</address>
        <city>Iranshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9914786138</zip>
        <telephone>+98 54 3721 0483</telephone>
        <email>mshahnavazi1392@gmail.com</email>
        <affiliation>Iranshahr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>maryam rigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranshahr, Baluch Blvd., Vice Chancellor for Education, Iranshahr University of Medical Sciences</address>
        <city>Iranshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9914786138</zip>
        <telephone>+98 54 3721 0483</telephone>
        <email>rigimaryam@gmail.com</email>
        <affiliation>Iranshahr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No diseases such as diabetes, epilepsy, hypotension, kidney and liver problems
No history of mourning in the last 6 months
No hospitalization in the last 6 months
Do not take certain medications such as anti-depressant, anti-anxiety and hypnotic
Not participating in counseling classes with psychologists
Score 5 or more on the "Pittsburgh Sleep Quality Index"
Lack of sensitivity to medicinal plants</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>24 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue cooperation
Do not use Salvia Officinalis tea for three nights
Unfortunate events (death of loved ones, divorce of parents and accident)
Getting sick and hospitalized
Pregnancy
Breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorders not due to a substance or known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group brews ten grams of sage and receives it every night, before going to bed for a month</i_keyword>
      <i_keyword>Control group:Control group: This group of placebo, which is brown sugar in the amount of ten grams, is inhaled and received every night before going to bed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Salvia Officinalis may improve the quality of students' sleep. Timepoint: Students' quality score according to the "Pittsburgh Sleep Quality Index" should be below six. Method of measurement: Pittsburgh Sleep Quality Index.</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>Iranshahr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-21</approval_date>
        <contact_name>Ethics committee of Iranshahr University of Medical Sciences</contact_name>
        <contact_address>Balooch St. Iranshahr Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
