<?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>IRCT20200926048840N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Persian medicine product on the recovery and relapse of bacterial vaginosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of traditional medicine product and metronidazole vaginal gel in the treatment and prevention of recurrence in patients with bacterial vaginosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51636</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We prepare 60 envelopes and numbers from one to 60. We prepare and print random numbers with the help of the Randomaize.com site and put them inside the envelopes. Capsules and tubes with the same shape and same number are put in the same envelopes based on a random allocation list by a person outside the research project. We ask patients to choose an envelope containing a number and to receive the relevant medicine envelope according to the number, Blinding description: The capsules and tubes in the same shape and number are placed in numbered envelopes and therefore participants, researchers and data analysts are unaware of the intervention and control groups. Only the sample allocator to the groups is aware of the control and intervention group.</study_design>
      <phase>3</phase>
      <hc_freetext>Bacterial vaginosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 10% vaginal gel prepared from aqueous extract of rhubarb root and oral capsule containing 200 mg of aqueous extract of rhubarb root will be used for a week to treat bacterial vaginosis. Intervention 2: Control group: Vaginal gel 0.75% metronidazole and placebo capsules will be used by the samples for a week to treat bacterial vaginosis.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is not no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sedigheh Moosaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3884 8931</telephone>
        <email>Mousaeis941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe Motavasselian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Iranian and Complementary Medicine, East Door, University Campus, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177899191</zip>
        <telephone>+98 51 3884 8930</telephone>
        <email>MotavasselianM@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women
18 -50 years old
Positive at least 3 out of 4 Amsel criteria</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
Lactation 
Menopause
Vaginal bleeding
Use of antibiotics in the last 4 weeks
Known chronic diseases
Using oral contraceptives to prevent pregnancy
Smoking and Consuming alcohol
Using Coumarin anticoagulants
Multiple sexual partners
Diarrhea</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Acute vagi</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>N76.0</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: 10% vaginal gel prepared from aqueous extract of rhubarb root and oral capsule containing 200 mg of aqueous extract of rhubarb root will be used for a week to treat bacterial vaginosis.</i_keyword>
      <i_keyword>Control group: Vaginal gel 0.75% metronidazole and placebo capsules will be used by the samples for a week to treat bacterial vaginosis</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cure (Elimination of all Amsel criteria or remaining only one criterion and according to the agent scoring system, a score of 1 to 3 or 4 to 6 without key cells). Timepoint: 10 days after the start of treatment and 30 days after the end of treatment. Method of measurement: Amsel and Najnat criteria.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vaginal discharge. Timepoint: 10 days after the start of treatment and 30 days after the end of treatment. Method of measurement: observation.</sec_outcome>
      <sec_outcome>Vaginal acidity. Timepoint: 10 days after the start of treatment and 30 days after the end of treatment. Method of measurement: Ph strip.</sec_outcome>
      <sec_outcome>Whiff test. Timepoint: 10 days after the start of treatment and 30 days after the end of treatment. Method of measurement: Koh 10% solution.</sec_outcome>
      <sec_outcome>Clue cells. Timepoint: 10 days after the start of treatment and 30 days after the end of treatment. Method of measurement: Evaluation of clue cells in the wet lam.</sec_outcome>
      <sec_outcome>Nagnet  score. Timepoint: 10 days after the start of treatment and 30 days after the end of treatment. Method of measurement: Evaluation of stained slide.</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>2020-09-12</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad University Of Medical Sciences, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
