<?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>IRCT20131110015349N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-11</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment ofvaginal infection</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment of fungal and bacterial infections and wound healing and vaginal inflammations</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70392</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization model was used, using a lottery. In this way, 100 people who came to the office and met the entry criteria were assigned a number, then all the numbers were thrown into a ball and one person was selected by lottery. The intervention group and one person was assigned to the control group, Blinding description: Participants do not know whether they are in the drug or placebo group. The herbal medicine is powdered and poured into a dark capsule cover, so that the contents cannot be seen. Placebo capsules are filled with dark colored flour. The participant does not know whether the capsule they are receiving is placebo or treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Inflammatory disease of cervix uteri. Condition 2: Candidiasis of vulva and vagina. Condition 3: Vaginitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study,  "the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules from Daru Darman Mahsan Nafis with limited responsibility by registration number 4831 on the dependent variables of fungal and bacterial infections and vaginal inflammations in women is investigated. On the other hand, the study will be conducted in case and control groups, and the allocation of control and case groups was random. This clinical trial, single-blind, placebo-controlled, and two-group before and after, will be conducted on 100 people with vaginal infections who will visit the women's office in Isfahan during 2023. Intervention 2: Control group: In the control group, a pap smear was taken first, and then a placebo was given to the patient, and after one month the results of the pap smear were checked.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is confidentiality</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Allahdadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Boulevard, Islamic Azad University, Falavarjan branch</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8451731167</zip>
        <telephone>+98 31 3742 0134</telephone>
        <email>maryamallahdadian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Allahdadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Boulevard, Islamic Azad University, Falavarjan branch</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8451731167</zip>
        <telephone>+98 31 3742 0134</telephone>
        <email>maryamallahdadian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>.Willingness to participate in the study
They have a vaginal infection</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have a history of diseases that weaken the immune system, diabetes, or metabolic diseases
They are taking chemical drugs for vaginitis.
Unwilling patients will be excluded from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N72</hc_code>
      <hc_code>B37.3</hc_code>
      <hc_code>N76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inflammatory disease of cervix uteri</hc_keyword>
      <hc_keyword>Candidiasis of vulva and vagina</hc_keyword>
      <hc_keyword>Acute vaginitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study,  "the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules from Daru Darman Mahsan Nafis with limited responsibility by registration number 4831 on the dependent variables of fungal and bacterial infections and vaginal inflammations in women is investigated. On the other hand, the study will be conducted in case and control groups, and the allocation of control and case groups was random. This clinical trial, single-blind, placebo-controlled, and two-group before and after, will be conducted on 100 people with vaginal infections who will visit the women's office in Isfahan during 2023.</i_keyword>
      <i_keyword>Control group: In the control group, a pap smear was taken first, and then a placebo was given to the patient, and after one month the results of the pap smear were checked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inflammation. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Pap smear result.</prim_outcome>
      <prim_outcome>Fungal infections. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Pap smear result.</prim_outcome>
      <prim_outcome>Bacterial infection. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Pap smear result.</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>Daru Darman Mahsan Nafis with limited responsibility by registration number 4831</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-29</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University- Najafaba Branch</contact_name>
        <contact_address>University Boulevar, Islamic Azad University, Najaf Abad branch Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
