<?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>IRCT20160308026971N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-29</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of aromatherapy with Jasmine and Clary sage oils on sexual dysfunction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of aromatherapeutic effect of  Jasmine and Clary sage oils on sexual dysfunction of women of reproductive age</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>168</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61233</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are assigned randomly using a random number table, and used to hide consecutive opaque envelopes numbered from 1 to 168. After random allocation, eligible individuals will be placed in one of four groups of aromatherapy with Jasmine, Clary sage, placebo (Sweet almond) or control, Blinding description: The oils under study are blinded by the company and delivered with the letters B, A and C by the research team and given to women of Reproductive age by a researcher or colleague. Questionnaires and checklists with codes C, B, A and D will be provided to participants. The completed questionnaires will be provided to the statistical consultant for analysis and thus the participants, researcher, colleague and statistical consultant are unaware of the type of oil and the study will be of the three blind type.</study_design>
      <phase>3</phase>
      <hc_freetext>Sexual disorder.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: 2 drops 2 times a day on the back of the upper lip (under the nose) as an aromatherapy of Clary sage oil 45% with sweet almond oil base for 6 weeks, prepared from the shoot (steam distillation of buds and leaves Plant) by Bain-marie method, made by Dr. Oil Company of Isfahan. Intervention 2: Second intervention group: 2 drops 2 times a day on the back of the upper lip (under the nose) as an aromatherapy of jasmine flower oil 50% with sweet almond oil base for 6 weeks, prepared from the plant flower by Bain-marie method, made by Dr. Oil Company of Isfahan. Intervention 3: Third intervention group (placebo): 2 drops 2 times a day on theback of the upper lip (under the nose) as an aromatherapy of sweet almond oil for 6 weeks, prepared from the brain (squeezing and oiling) by cold press method, made by Dr. Oil Company of Isfahan. Intervention 4: Control group: Failure to receive intervention. Complete the questionnaire twice 6 weeks apart.</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>Marzeyeh Loripoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse St., Faculty of Nursing and Midwifery</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3428 0035</telephone>
        <email>marzeyehloripoor@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzeyeh Loripoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse St., Faculty of Nursing and Midwifery</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3428 0035</telephone>
        <email>marzeyehloripoor@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality
Monogamy
Be in the range of reproductive ages (15 to 45 years)
Existence of sexual dysfunction (according to the score obtained from the questionnaire, score less than 28)
Having vaginal sex at least once a week</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy and Breastfeeding
Use of any drug that affects a person's sexual response
Drug use in couples
Existence of known psychological problems or systemic diseases affecting sexual function in the couple according to the individual (cardiovascular disease, diabetes, lower urinary tract symptoms, rheumatoid arthritis, urinary incontinence, anxiety, obsession and depression)
Existence of olfactory disturbance and other disorders related to the nose according to the individual
Existence of digestive disorders such as nausea, vomiting following inhalation of various odors
Existence of obvious and important interpersonal problems between husband and wife, according to the wife
History of allergies to the studied oils
Existence of obvious vaginal infection according to the person's own statement</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other sexual disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: 2 drops 2 times a day on the back of the upper lip (under the nose) as an aromatherapy of Clary sage oil 45% with sweet almond oil base for 6 weeks, prepared from the shoot (steam distillation of buds and leaves Plant) by Bain-marie method, made by Dr. Oil Company of Isfahan.</i_keyword>
      <i_keyword>Second intervention group: 2 drops 2 times a day on the back of the upper lip (under the nose) as an aromatherapy of jasmine flower oil 50% with sweet almond oil base for 6 weeks, prepared from the plant flower by Bain-marie method, made by Dr. Oil Company of Isfahan.</i_keyword>
      <i_keyword>Third intervention group (placebo): 2 drops 2 times a day on theback of the upper lip (under the nose) as an aromatherapy of sweet almond oil for 6 weeks, prepared from the brain (squeezing and oiling) by cold press method, made by Dr. Oil Company of Isfahan.</i_keyword>
      <i_keyword>Control group: Failure to receive intervention. Complete the questionnaire twice 6 weeks apart.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual dysfunction score. Timepoint: Before the intervention, the end of the intervention. Method of measurement: Female Sexual Function Index (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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-10</approval_date>
        <contact_name>Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>No. 7, Alley 11, Kargar Ave Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
