<?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>IRCT20090304001742N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-19</date_registration>
      <primary_sponsor>Larestan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of lavender and chamomile herbal tea on anxiety and depression in postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of lavender and chamomile herbal tea on anxiety and depression in postmenopausal women: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50251</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the list of community health centers in Larestan city that postmenopausal women refer to for health services is written on paper. In the next step, the name of each center is placed in a separate envelope and a simple envelope is selected at random. . Assisting the researcher to refer to the selected health center by using available sampling and applying the conditions for entering and leaving the study, sampling postmenopausal women. The selected samples are placed in each of the intervention groups or the control group according to the randomized blocks according to the inclusion in the study. Thus, according to the sample size of this study, which is estimated at 96 people, 8 blocks of 12 are used. This means that in each block, 4 people are in the intervention group of lavender tea, 4 people are in the chamomile tea intervention group and 4 people are in the control group. Sampling continues until 8 blocks are completed. Finally, 32 people in each group are selected in randomized blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and depression in postmenopausal women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:includes the use of 2 grams of dried leaves of lavender, which is boiled twice in the morning and evening (Dried lavender flowers are placed in 300 ml of boiling water for 10-15 minutes) and consumed daily with candy in the form of 2 cups of lavender herbal tea. Intervention 2: Intervention group: includes the use of 2 grams of dried leaves of Chamomile, which is boiled twice in the morning and evening (Dried Chamomile flowers are placed in 300 ml of boiling water for 10-15 minutes) and consumed daily with candy in the form of 2 cups of Chamomile herbal tea. Intervention 3: Control group: In this study, the control group did not receive any intervention.</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' information can be shared after it becomes unrecognizable

When:
Access begins a year after the publication of results

To whom:
People who are working in the academic and scientific institutions

Conditions:
It needs the agreement of Larestan University of Medical Sciences

Where to obtain:
Dr. Mohammad Rafi Bazrafshan, Associate Professor, Larestan School of Medical Sciences, Email: m.bazrafshan@larums.ac.ir, Contact Phone: 07152247110, Mobile Number: 09173821959

How to obtain:
Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad-Rafi Bazrafshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county</address>
        <city>Larestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7431889629</zip>
        <telephone>+98 71 5225 5512</telephone>
        <email>m.bazrafshan@larums.ac.ir</email>
        <affiliation>Larestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Larestan University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county</address>
        <city>Larestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7431889629</zip>
        <telephone>+98 71 5225 5512</telephone>
        <email>m.bazrafshan@larums.ac.ir</email>
        <affiliation>Larestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 45 years
Do not use alternative therapies such as hormone therapy
Achieve mild to moderate depression score (score 14 to 28)
Having informed consent to participate in research
Ability to swallow and no oral or digestive problems that do not interfere with drinking.
Having the necessary vigilance to complete the questionnaires
Depression and anxiety disorder are not the result of physical problems such as hypothyroidism.
Candidates should not participate in other treatment programs that interfere with the present study.
Regular use of tea according to the treatment plan</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance of samples to participate in research
History of allergy to herbal medicines
Addiction to drugs and alcohol and painkillers
Taking psychiatric drugs
Having severe depression or anxiety</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Depression</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:includes the use of 2 grams of dried leaves of lavender, which is boiled twice in the morning and evening (Dried lavender flowers are placed in 300 ml of boiling water for 10-15 minutes) and consumed daily with candy in the form of 2 cups of lavender herbal tea.</i_keyword>
      <i_keyword>Intervention group: includes the use of 2 grams of dried leaves of Chamomile, which is boiled twice in the morning and evening (Dried Chamomile flowers are placed in 300 ml of boiling water for 10-15 minutes) and consumed daily with candy in the form of 2 cups of Chamomile herbal tea.</i_keyword>
      <i_keyword>Control group: In this study, the control group did not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety and depression. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Spielberger Anxiety Questionnaire - Beck Depression 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>Larestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-30</approval_date>
        <contact_name>Ethics committee of Larestan University of Medical Sciences</contact_name>
        <contact_address>Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county, Fars province, Iran Larestan Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
