<?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>IRCT20160423027534N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-04</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vaginal cream Prangos ferulacea Brghvnt Trichomonas vaginalis</public_title>
      <acronym>TVI</acronym>
      <scientific_title>Comparison of treatment with oral metronidazole vaginal cream Prangos ferulacea with oral metronidazole vaginal cream with placebo in the treatment of Trichomonas vaginalis infection in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34045</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Available (simple) based on the target.
In this way, all patients who have conditions of entry to the study, are examined. The delivery of drugs to patients is such that, in a box, a number of cards matching them equally, the letters of the English alphabet "A A" and "B" correspond to the vaginal cream code of the placebo and Prangos ferulacea  (the researcher does not know the worms' content), and Patients randomly select a card and deliver the medicine according to the letters on the card, Blinding description: This study is a randomized, triangular blind clinical trial. The diagnosis of Trichomonas slides be encoded and the patient's name is not written. At the stage of giving the patient, the Prangos ferulacea vaginal cream and placebo are marked with the English letters A and B, which are coded by the pharmacist. The researcher is unaware of its contents, and the patient will randomly choose one of the vaginal creams. In the referral stage after treatment, the slides are also examined by another researcher. And the professor of statistics is also unaware of the control and intervention group.</study_design>
      <phase>3</phase>
      <hc_freetext>Trichomoniasis vaginit.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days with our Prangos ferulacea vaginal cream. Intervention 2: Control group:metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days with our plasebo vaginal cream.</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 no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asieh Azadpourmotlagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>azadpurmotlagh@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asieh Azadpourmotlagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>azadpurmotlagh@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 15-49 year old married women
Non pregnant
Non  breast feeding
Non menopause
Non smoker
Willing to participate in the research
Complaine with foamy yellow green discharge
Not having vaginal infections
Not having unusual vaginal bleeding during the treatment
Not intercoursing during the treatment
Not using vaginal ointment,suppository or douching from two days before treatment
Not having chronic diseases like heart or kidney problems, diabetes, arthoritis
Not using broad-spectrum antibiotics, hormones, anticoagulant and immunosuppressive medicine
Not having   allergic to metronidazole or topical medications</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria: Unwilling to continue to participate in the reseach
Not using vaginal ointment for two consecutive days
Being allergic to metronidazole or Prangos ferulacea vaginal cream or intolerance to any forms of medicine
Having vaginal infections (bacterial vaginosis and candidiasis)
having intercourse during in the treatment
become pregnant during treatment
incomplete questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A59.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Trichomonal vulvovaginitis</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:  metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days with our Prangos ferulacea vaginal cream.</i_keyword>
      <i_keyword>Control group:metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days with our plasebo vaginal cream.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1- Evaluation of vaginal secretions in terms of color, odor by direct observation.2. Transient trichomoniasis (under microscope) in wet smear. Timepoint: Before interference and 7 days after treatment. Method of measurement: At first, the secretions and symptoms will be examined with direct vision. Then, using sterile cotton swabs, a vaginal discharge was taken and a 10% potassium solution was prepared on a lavender discharge prepared with sterile cotton swabs. And immediately poured a drop of saline samples under a microscope with a magnification of 400 (× 40) was seen moving trophozoite information.</prim_outcome>
      <prim_outcome>Observe the wet slides with a microscope. Timepoint: Before interference and 7 days after treatment. Method of measurement: With sterile cotton swabs, a sample of the secretions of the side walls of the vagina was removed and immediately underneath the microscope with magnification (× 40). If trichomoniasis is present in wet pearl trophozoites, they are approved.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Trichomoniasis vaginitis. Timepoint: En Before the intervention, seven days after start treatment. Method of measurement: Samples are discharge from the sample by using the pH meter Strip, and after wetting the pH Strip, the color will change, and if the pH of the vaginal discharge is between 6-5, a wet test is performed.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-02</approval_date>
        <contact_name>National Committee of Ethics in Biomedical Research</contact_name>
        <contact_address>Faculty of Nursing &amp; Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
