<?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>IRCT20200129046301N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-14</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Violet plant vaginal gel and metronidazole vaginal gel in treatment of bacterial vaginosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Violet plant vaginal gel and metronidazole vaginal gel in treatment of bacterial vaginosis in women of reproductive age</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45580</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 88  women with BV will be randomly assigned to the Violet and  metronidazole groups. Randomization with random quadruple blocks,  block size 4, will be done using computer software. Metronidazole and Violet labels will  be encrypted as A or B by someone unaware of the purpose of the study. The formulations of Violet and metronidazole  will be similar in appearance and consistency. The person who will distributed among the subjects will not be aware of the purpose of study, Blinding description: In this study, is blinding allocation in such a way that the drugs will be coded by the pharmacist ( A, B) and the pharmacist will need 50gr of each type of metronidazole gel 0.75% and 50gr violet gel 5%,  will be poured separately into tube of one color and shape and the taboos will be coded at the pharmacists discretion, so that only the pharmacist knows which drug A belongs to and the code B belongs to which is the drug. The research units and researcher will not have any information about the nature of the drugs untile the end of the research and after analyzing the data.</study_design>
      <phase>3</phase>
      <hc_freetext>Bacterial vaginosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Vaginal gel of violet plant oil 5%,  50 mgr,  made by  Ahwaz School of Pharmacy 5 mg every night applicator vaginally for 7 nights. Intervention 2: Control group: Metronidazole vaginal  gel 0.75%,  50 mg, made by Behvazan Pharmaceutical Company 5 mg every night with applicator vaginally for 7 nights.</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 The purpose of this decision is to prevent  disclose personal information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Afsharnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jundishapur University of Medical Sciences, Golestan Blv,  Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3222 2114</telephone>
        <email>afsharnia.p @ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Iravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jundishapur University of Medical Sciences, Golestan Blv,  Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3222 2114</telephone>
        <email>minairavani2004@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The criteria for entering the study: Married non-pregnant and non-lactating women 15 -44 Years old, diagnosis of bacterial vaginosis based on at least 3 out of 4 Amsel criteria and score 4 to 6 with clue cells or a score of 7 to 10 without the presence of clue cells frome the Nugent scoring system,  willingness to participate to study,  possibility to attending center in schedule time for post treatment follow up, Filling the Informed Consent Form.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria: Vaginal bleeding, Frequently vulvovaginits, Candidiasis, Trichomonas vaginalis, Pregnancy,  Mensturation,  Breastfeeding,  Frequent Use of vaginal douches, Consuming alcohol and coumarin anticoagulants and recent use of anti-parasit drugs, Anti-biotic drugs, Immunosuppressive drugs, Multiple sexual partner, Specific diseases such as liver, kidney diseases and central nervous system diseases, Blood dyscrasis, Diabetes, Weakening of the immune system, Sexually transmitted diseases, History of sensitive to the forme of temperament Rocky and topical, History sensitive to metronidazol tablet.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute vaginitis</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: Vaginal gel of violet plant oil 5%,  50 mgr,  made by  Ahwaz School of Pharmacy 5 mg every night applicator vaginally for 7 nights.</i_keyword>
      <i_keyword>Control group: Metronidazole vaginal  gel 0.75%,  50 mg, made by Behvazan Pharmaceutical Company 5 mg every night with applicator vaginally for 7 nights.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Treatment of bacterial vaginosis. Timepoint: 1 and 4 weeks after the intervention. Method of measurement: According to Amsel criteria: Examination of (vaginal discharge,  color,  acidity,   presence of clue cells,  Whiff test ).</prim_outcome>
      <prim_outcome>Empty. Timepoint: Empty. Method of measurement: Empty.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vaginal discharge. Timepoint: Before  starting the intervention, 1 and 4 weeks after the intervention. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Vaginal acidity. Timepoint: Before  starting the intervention, 1 and 4 weeks after the intervention. Method of measurement: Ph strip.</sec_outcome>
      <sec_outcome>Whiff test. Timepoint: Before  starting the intervention, 1 and 4 weeks after the intervention. Method of measurement: Koh 10%.</sec_outcome>
      <sec_outcome>Clue cells. Timepoint: Before  starting the intervention, 1 and 4 weeks after the intervention. Method of measurement: Evaluation of clue cells in the wet lam.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-17</approval_date>
        <contact_name>Ethics committe of Ahvaz jundishapour university of medical science</contact_name>
        <contact_address>No.  234,  Golestan Blv,  Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
