<?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>IRCT201207153226N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-20</date_registration>
      <primary_sponsor>The International Branch of Shahid Beheshti university of medical sciences</primary_sponsor>
      <public_title>The comparison of the effect of garsin and metronidazole on bacterial vaginosis</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effects of garsin tablet ( made of garlic ) and metronidazole tablet on treatment of bacterial vaginosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3291</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bacterial vaginosis infection.</hc_freetext>
      <i_freetext>Intervention 1: One group Metronidazole 250 mg tablet, twice daily 500 mg (every 12 hours) with food for 7 days. Intervention 2: the other group Garsin 500 mg tablet, twice daily 1000 mg (every 12 hours) with meal for 7 days.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnaz Mohammadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St. Valiasr, intersection of Valiasr -Niyayesh, School of nursing and midwifery,  shaheed Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>farnaz.mohammadzade@gmail.com; sbnmf@sbmu.ac.ir</email>
        <affiliation>The International Branch of Shahid Beheshti university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Mohammadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St. Valiasr, intersection of Valiasr -Niyayesh, School of nursing and midwifery,  shaheed Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>farnaz.mohammadzade@gmail.com; sbnmf@sbmu.ac.ir</email>
        <affiliation>The International Branch of Shahid Beheshti university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: married women; aged 18-44 years old, with single partner whose infection with bacterial vaginosis is diagnosed through clinical Amsel criteria and labratory Nugent criteria ( Patients identified with cervicitis tricamona or candidiadis infections are excluded from the study); they should not use IUD. Also they should not use antibiotics, vaginal drug or immunosuppressive drugs in recent fourteen days. During clinical examination they should not have any breakthrough bleeding or menstrual period. They should not be pregnant, lactating or menopause. They should not have mental retardation or known physical disease; suffering from thyroid disease; coagulation disorders; diabetes and autoimmune diseases. Exclusion criteria: not tolerate any form of drug or  discontinuation for at least 48 hours, become pregnant during treatment, forcing the use of antibiotics during treatment.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N77</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vulvovaginal ulceration and inflammation in diseases classified elsewhere</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>One group Metronidazole 250 mg tablet, twice daily 500 mg (every 12 hours) with food for 7 days</i_keyword>
      <i_keyword>the other group Garsin 500 mg tablet, twice daily 1000 mg (every 12 hours) with meal for 7 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amsel criteria. Timepoint: Before the intervention, 7-10 days after begining of treatment. Method of measurement: Amsel have 4 criteria: key cells in the wet mount vaginal sample Vaginal dyscharge thin and white uniform - gray, white or yellowish, Vaginal pH equal to or greater than 4/5, positive whiff test. If at least 3 of the 4 cases mentioned above is positive, bacterial vaginosis is brought on .</prim_outcome>
      <prim_outcome>Nugent criteria. Timepoint: Before the intervention, 7-10 days after beginning treatment. Method of measurement: These criteria are based on the observation lactobacil and other morphotype (Gardnerella vaginalis  and Mobiluncus forms) are rated from zero to 10 points, a total score of 7-10  means abnormal vaginal flora (bacterial vaginosis), grades 4-6 (Intermediate) in this study means abnormal vaginal flora. normal flora score is 0-3.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bacterial vaginosis infection. Timepoint: Before the intervention, 7-10 days after beginning treatment. Method of measurement: Clinical complaint questionnaires are completed by samples (itching, burning, abnormal discharge, smelly discharge).</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>The International Branch of Shahid Beheshti university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-07</approval_date>
        <contact_name>The International Branch of Shahid Beheshti university of medical sciences &amp; health sciences</contact_name>
        <contact_address>No.19, Adjacent to Hemmat bridge, shaheed Abbaspour ave, Valiasr street,Tehran.Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
