<?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>IRCT20220621055245N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-16</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy with Rose petal aqueous extract on sexual function of postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aromatherapy with Rose petal aqueous extract on sexual function of postmenopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>57</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64325</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling in random categories will be proportional to the volume of floors, so that each of the comprehensive health service centers in Gonabad is considered as a floor and from each center is calculated according to the sample size and proportional to the number The population covered by each center, from the list of covered people, research samples will be randomly selected and randomly assigned to the aromatherapy or control group using permutation blocks.Random permutation blocks of sizes 2 and 4 will be used for randomization. The analyzer will determine the randomization list based on a web-based randomization program. The allocation will be concealed using opaque sealed envelopes with a random sequence, Blinding description: Blinding will be done for the data analyzer. For the study groups, A and B codes are considered, and the data analyzer is not told the type of intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>The effect of rosemary extract on postmenopausal women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, 2-3 drops of 10% rosehip solution (prepared at Pars Tek Rokh Company) are inhaled three times a day for 6 weeks on the forearm to ensure the correctness of the intervention, once a week. The participants will be contacted and a daily checklist will be given to the people to mark every day after the intervention and the complication form will be filled by the participants during the study in case of problems. Immediately after the end of the intervention (two weeks after the start of the intervention) and one month after the end of the intervention, the participants in both groups will complete the sexual performance index questionnaire again. Intervention 2: Control group: Distilled water solution is inhaled 3 times a day for 6 weeks on the forearm. In order to ensure the correctness of the intervention, the participants are contacted once a week and a daily checklist is given to the individuals to mark every day after the intervention, and the complication form during the study in case of any problem by the participation. will be filled. Immediately after the end of the intervention (two weeks after the start of the intervention) and one month after the end of the intervention, the participants in both groups will complete the sexual performance index questionnaire again.</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:
Participants are coded to increase access to them and their information, but at the time of publication, only the main outcome is published and the participants' information is not published at all.

When:
6 months after printing the results

To whom:
Access is open to the public

Conditions:
If people request, without mentioning the coding of information confidentially, without personal information, only the main and side consequences will be provided to the applicant.

Where to obtain:
E-mail

How to obtain:
The applicant must first e-mail the message and state its use. Information will be sent within a week with conditions and restrictions for use.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasrin Vahdani Rashvanlouyi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 September South .Farabi .Nabsh Farabi 3 No. 49</address>
        <city>Boujnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9413653514</zip>
        <telephone>+98 58 3242 4581</telephone>
        <email>vahdani.n.midwifery@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Vahdani Rashvanlouyi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 September South .Farabi .Nabsh Farabi 3 No. 49</address>
        <city>Boujnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9413655314</zip>
        <telephone>+98 58 3242 4581</telephone>
        <email>vahdani.n.midwifery@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 45 and 60 years,                                                                  
menopause occurs naturally,                                                                      
more than 12 months have passed since the last menstruation, 
living with a spouse and having sexual activity,                          
body mass index 18.5 to 29.9,                                                
absence of addiction and drug use,                                                                     
not using any drugs that affect Sexual function,                           
not having a known systemic disease affecting sexual function, 
no disturbance in the sense of smell                                                                       
No history of using aromatherapy,                                                                 
no sensitivity to rosehip compounds,                                                                   
no problem of spouse in sexual relations,                           
obtaining the quorum score in the DASS_21 questionnaire, obtaining the quorum score in the FSFI questionnaire at the level of moderate sexual dysfunction</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to enter the study
Not having a sexual partner
premature menopause
People do not have the ability to understand Farsi language
The presence of psychiatric problems
History of hospitalization in psychiatric hospitals</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>Intervention group: In the intervention group, 2-3 drops of 10% rosehip solution (prepared at Pars Tek Rokh Company) are inhaled three times a day for 6 weeks on the forearm to ensure the correctness of the intervention, once a week. The participants will be contacted and a daily checklist will be given to the people to mark every day after the intervention and the complication form will be filled by the participants during the study in case of problems. Immediately after the end of the intervention (two weeks after the start of the intervention) and one month after the end of the intervention, the participants in both groups will complete the sexual performance index questionnaire again.</i_keyword>
      <i_keyword>Control group: Distilled water solution is inhaled 3 times a day for 6 weeks on the forearm. In order to ensure the correctness of the intervention, the participants are contacted once a week and a daily checklist is given to the individuals to mark every day after the intervention, and the complication form during the study in case of any problem by the participation. will be filled. Immediately after the end of the intervention (two weeks after the start of the intervention) and one month after the end of the intervention, the participants in both groups will complete the sexual performance index questionnaire again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function. Timepoint: At the beginning of the study, immediately after the intervention (two weeks after the start of the intervention) and one month after the intervention, participants in both groups will complete the sexual function index questionnaire again. Method of measurement: ّFSFI questionnaire.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-06</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Scienses</contact_name>
        <contact_address>17 September South .Farabi .Farabi 3. No. 49 Bojunord North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
