<?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>IRCT20190406043175N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-23</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Tamarix gallica extract in treatment of gingivitis</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effectiveness of Tamarix gallica on the treatment of patients with gingivitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55721</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial, 56 patients were assigned to the dental faculty with mild to moderate gingivitis. The informed consent was completed and included the study. By using simple randomization method, 28 cards are selected by the researcher as the first group and the same number of cards for the next group. Then, by merging the cards together (by adding the cards), a card is taken out and its allocation is recorded, and that card is returned to the other cards by merging the cards together (by adding the cards). The cards then merge again and another card will have picked up. This process continues to reach a random sequence according to sample size. The patients divided equally into two groups of drugs (4% Tamarix gallica extract), control (0.2% chlorhexidine), Blinding description: In this double-blind study mouthwash is given to patients non-labeled, and the periodontist is unaware of which mouthwash is given to each group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Gingivitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: mouthwash containing 4% hydroalcoholic extract of Tamarix gallica .For each patient, 10 ml of Tamarix gallica extract two times a day for 2 weeks is administered. Tamarix gallica extract is prepared by pharmacological research center of medical plants. The indices are evaluated in the first week and one month later by periodontist. Intervention 2: Control group: Chlorheddine 0.2% produced by Behsa Iran Co.For each patient, 10 ml of mouthwash two times a day for 2 weeks is administered. The indices are evaluated in the first week and one month later by periodontist.</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:
Gingivitis index, plaque index, pocket depth, Bleeding on probing

When:
6 months after publication

To whom:
Medical universities

Conditions:
Any evaluation and analysis must be done under the supervision of executor of the project

Where to obtain:
Sending email to executor of the project

How to obtain:
Sending email to executor of the project and the response up to 1 week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassan Rakhshandeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacological Research Center of Medicinal Plants,. Faculty of Medicine, Pardis campus, Azadi square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177899191</zip>
        <telephone>+98 51 3882 8566</telephone>
        <email>rakhshandehh@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Rakhshandeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacological Research Center of Medicinal Plants,. Faculty of Medicine, Pardis campus, Azadi square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177899191</zip>
        <telephone>+98 51 3882 8566</telephone>
        <email>Rakhshandehh@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gingivitis patients
All of these patients had at least 20 permanent teeth</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Need to prescribe antibiotics to treat gingivitis
Taking anti-inflammatory drugs during the study period
Taking anticoagulants drugs during the study period
Pregnancy and breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic gingivitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: mouthwash containing 4% hydroalcoholic extract of Tamarix gallica .For each patient, 10 ml of Tamarix gallica extract two times a day for 2 weeks is administered. Tamarix gallica extract is prepared by pharmacological research center of medical plants. The indices are evaluated in the first week and one month later by periodontist.</i_keyword>
      <i_keyword>Control group: Chlorheddine 0.2% produced by Behsa Iran Co.For each patient, 10 ml of mouthwash two times a day for 2 weeks is administered. The indices are evaluated in the first week and one month later by periodontist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gingivitis index. Timepoint: At baseline, week 1 and week 4 of the trial. Method of measurement: Examination by periodontist with periodontal Williams probe.</prim_outcome>
      <prim_outcome>Plaque index. Timepoint: At baseline, week 1 and week 4 of the trial. Method of measurement: Examination by periodontist with periodontal Williams probe.</prim_outcome>
      <prim_outcome>Pocket depth. Timepoint: At baseline, week 1 and week 4 of the trial. Method of measurement: Examination by periodontist with periodontal Williams probe.</prim_outcome>
      <prim_outcome>Bleeding on probing. Timepoint: At baseline, week 1 and week 4 of the trial. Method of measurement: Examination by periodontist with periodontal Williams probe.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-11</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Faculty of medicine, University campus, Azadi square, Mashhad university of Medical sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
