<?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>IRCT20210223050471N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of  cream Artemisia absinthium on Sexual function and sexual satisfaction and quality of sexual life .</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Vaginal cream Artemisia absinthium on Sexual function and sexual satisfaction and quality of sexual life of postmenopausal women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61189</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the permutation block method is used to generate a sequence of random allocation of individuals to the study groups. Random allocation sequences are performed using random allocation software and block size two. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied, Blinding description: In this research, the researcher, participants and statistical analyst are blinded. In this way, the drugs that are placed in the same boxes and named by the pharmacist consultant (no one in the study except the pharmacist consultant knows the contents of the boxes) the boxes are given to the group of participants.</study_design>
      <phase>3</phase>
      <hc_freetext>Sexual function, sexual satisfaction, quality of sexual life.</hc_freetext>
      <i_freetext>Intervention 1: For 4 weeks and 3 times a week (before going to bed) and if you are  intercourse during these 3 times 30 minutes before sexual intercourse, an applicator of 5% wormwood herbal cream will be used vaginally. In 4 weeks, 12 applicators of the cream should be used. Each applicator is equivalent to 250 mg of wormwood extract. Intervention 2: Control group: The same cream without wormwood extract for 4 weeks and 3 times a week (before bedtime) and if you have intercourse in these three times, 30 minutes before, an applicator of the cream will be used vaginally. In 4 weeks, 12 applicators of the cream should be used.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data will be shared after it becomes unrecognizable

When:
6 months after recording the results

To whom:
All researchers

Conditions:
All postmenopausal women have dysfunction and sexual satisfaction and low quality of sex life

Where to obtain:
Email niloofarhajatpoor@gmail.com Library of Mashhad School of Nursing to Mashhad, Daneshgah St.

How to obtain:
First, send a requested email and if you do not respond within a week, you can refer to the library of Mashhad School of Nursing.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Raheleh Babazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Babazadehr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Raheleh Babazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Babazadehr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age ranges 45-65 years
Married women
Having a hormonal test with an FSH level above 40
One year or more after the last menstrual period
Having sexual activity at least twice during a month of intervention time
No liver, kidney, heart, thromboembolic and psychological problems
No history of chemotherapy or radiation therapy to the pelvis or the whole body
Lack of consumption psychiatric drugs, fluoxetine, vitamin E, propranolol and other chemical or herbal medicines that affect the symptoms of menopause
Lack of consumption hormone replacement therapy
Lack of consumption tobacco, alcohol or drugs
Lack of depression (depression score 21 and above), no anxiety (anxiety score 15 and above), no stress (stress score 26 and above) of DASS-21 questionnaire
Sexual performance score below 28 of the Female Sexual Function Index questionnaire and sexual satisfaction score below 75 of the Larson Sexual Satisfaction Questionnaire</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use phytoestrogens in the diet such as soy, flaxseed, clover germ and alfalfa
Infection or vaginal bleeding of unknown cause</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>For 4 weeks and 3 times a week (before going to bed) and if you are  intercourse during these 3 times 30 minutes before sexual intercourse, an applicator of 5% wormwood herbal cream will be used vaginally. In 4 weeks, 12 applicators of the cream should be used. Each applicator is equivalent to 250 mg of wormwood extract.</i_keyword>
      <i_keyword>Control group: The same cream without wormwood extract for 4 weeks and 3 times a week (before bedtime) and if you have intercourse in these three times, 30 minutes before, an applicator of the cream will be used vaginally. In 4 weeks, 12 applicators of the cream should be used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual Performance Score. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Female Sexual Function Index (FSFI).</prim_outcome>
      <prim_outcome>Sexual satisfaction score. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire(LSSQ).</prim_outcome>
      <prim_outcome>Sexual quality of life score. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Female Sexual Quality of Life Questionnaire(SQOL-F).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-30</approval_date>
        <contact_name>Ethics Committee of the School of Nursing and Midwifery - Mashhad University of Medical Sciences</contact_name>
        <contact_address>University St., Qureshi Building, Mashhad University of Medical Sciences, Vice Chancellor for Research Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
