<?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>IRCT20191012045067N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-09</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the  effect of Thyme and Mint herbal tea on Salivary PH</public_title>
      <acronym>-</acronym>
      <scientific_title>Evaluation of the  effect of Thyme and Mint herbal tea on Salivary PH</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66308</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: -, Randomization description: Random assignment of participants to two groups is done by simple randomization method. In this way, the samples of eligible clients are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) that will be randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2 (Table 1).
Table 1: The practical method of assigning students to two groups with a simple randomization method
BAAB
AABB
BAAB
ABBA
BBAA
ABAB
AABB
ABBA
ABBA
AABB
ABAB
AABB
AABB
ABBA
BBAA
AABB
BAAB
BABA
BBAA
AABB, Blinding description: The participant and analyzer do not know the type of consumables and the consumables are numbered as 1 , 2.The substance is given to the participant in a glass with a coding matte lid and the analyzer records information only based on the desired code.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of  mint and thyme tea consumption  on salivary pH.</hc_freetext>
      <i_freetext>Intervention 1: Intervention  mint group In this group ,the participant receives mint tea(the composition of 100 grams of Saharkhiz mint powder in 250cc  boiled water) in 1 dose ( once). Intervention 2: Intervention group: thyme(the composition of 100 grams of Saharkhiz  thyme powder in 250 cc  boiled water)-In this group, the participant receives thyme tea  in 1 dose(once).</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>معصومه  شیرزایی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan-dental school</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817699693</zip>
        <telephone>+98 54 3344 1824</telephone>
        <email>shirzaiy@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>masoomeh shirzaiy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan-Dental school</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817699693</zip>
        <telephone>+98 54 3344 1824</telephone>
        <email>shirzaiy@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No systemic disease, ,
no history of drug use in the past 3 months,
no infection or acute or chronic dental or periodontal abscesses
no salivary gland disorders such as, stones, infection, neoplasms,
no  intravenous radiotherapy,
no history of smoking and drug use
no history of  Oral plaque use  such as orthodontic plaque,
no oral lesions
no periodontal problems</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unwillingness to cooperate
Age over 30 years</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention  mint group In this group ,the participant receives mint tea(the composition of 100 grams of Saharkhiz mint powder in 250cc  boiled water) in 1 dose ( once)</i_keyword>
      <i_keyword>Intervention group: thyme(the composition of 100 grams of Saharkhiz  thyme powder in 250 cc  boiled water)-In this group, the participant receives thyme tea  in 1 dose(once)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Salivary PH rate. Timepoint: Before use, 1.5 and 10 minutes after use. Method of measurement: ph meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Salivary ph change. Timepoint: Before starting the study - 1, 5 and 10 minutes after the intervention. Method of measurement: Digital ph meter device.</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>no</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-26</approval_date>
        <contact_name>دانشگاه علوم پزشکی زاهدان</contact_name>
        <contact_address>azadegan street-dental school zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
