<?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>IRCT20200818048452N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-05</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of chamomile tea on anxiety and depression in postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of chamomile tea on anxiety and depression in postmenopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51752</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed using a random number table to create quadruple blocks in a one-to-one ratio that will be placed in two groups of 30 people to intervene and control, Blinding description: In this study, participants did not know each person was placed in which group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and depression in postmenopausal women..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For this patient if they had the inclusion criteria, after submitting a description and obtaining informed consent, The DAAS-21 questionnaire and the demographic information form will be completed pre-intervention. Each patient consumes three sachets daily at least half an hour after each meal. In this way, 2.5 grams of dried German chamomile flowers made by Golestan factory are placed in 150 cc of boiling water every time. The duration of putting the tea in boiling water is the same for all people. Patients are followed up 4 weeks after the intervention and 8 weeks after the intervention and the DAAS-21 questionnaire is completed for them. Intervention 2: Control group: For this patient if they had the inclusion criteria, after submitting a description and obtaining informed consent, The DAAS-21 questionnaire and the demographic information form will be completed pre-intervention. In this group, the intervention is applied with the placebo that contains wheat germ powder. Each patient consumes three bags of placebo daily for at least half an hour after each meal. Each time, 2.5 grams of placebo, which is similar in shape and size to the chamomile tea bag made by Golestan factory, is placed in 150 cc of boiling water. The duration of putting the bag in the boiling water is the same for all participants. Patients are followed up 4 weeks after the intervention and 8 weeks after the intervention and the DAAS-21 questionnaire is completed for them. It should be noted that placebo contains wheat germ powder, which according to scientific articles and documents has no therapeutic effect on anxiety and depression.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Zamanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.79, West Azadeh 2 Ave., Moalem Blvd., Ahwaz Town</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794- 61357</zip>
        <telephone>+98 61 3621 0123</telephone>
        <email>‏‪zohrehzamanpour1400@gmail.com‬‏</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Abbaspoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd., Esfand Ave</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794- 61357</zip>
        <telephone>+98 61 3336 7543</telephone>
        <email>abbaspoor_z762@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Interested in participating in the study.
Having at least elementary education.
45-60 years old.
Amenorrhea for 1 year.
Mild to moderate anxiety and depression symptoms (according DASS scale).</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having allergy to chamomile.
Major depression that need to special treatment.
Person who have suicidal thoughts and self-harm.
Having renal, liver, cardiac and thyroid disease, Bleeding disorder and malignancies, degenerative, auto immune and psychological disorder.
Using of anti-depression and sedative drugs in 3 months ago.
Having a history of stressful events or tragic events in recent months such as the death of a spouse or close persons.
Having a history of drug abuser or alcohol abuse.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For this patient if they had the inclusion criteria, after submitting a description and obtaining informed consent, The DAAS-21 questionnaire and the demographic information form will be completed pre-intervention. Each patient consumes three sachets daily at least half an hour after each meal. In this way, 2.5 grams of dried German chamomile flowers made by Golestan factory are placed in 150 cc of boiling water every time. The duration of putting the tea in boiling water is the same for all people. Patients are followed up 4 weeks after the intervention and 8 weeks after the intervention and the DAAS-21 questionnaire is completed for them.</i_keyword>
      <i_keyword>Control group: For this patient if they had the inclusion criteria, after submitting a description and obtaining informed consent, The DAAS-21 questionnaire and the demographic information form will be completed pre-intervention. In this group, the intervention is applied with the placebo that contains wheat germ powder. Each patient consumes three bags of placebo daily for at least half an hour after each meal. Each time, 2.5 grams of placebo, which is similar in shape and size to the chamomile tea bag made by Golestan factory, is placed in 150 cc of boiling water. The duration of putting the bag in the boiling water is the same for all participants. Patients are followed up 4 weeks after the intervention and 8 weeks after the intervention and the DAAS-21 questionnaire is completed for them. It should be noted that placebo contains wheat germ powder, which according to scientific articles and documents has no therapeutic effect on anxiety and depression.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety and depression in postmenopausal women. Timepoint: Pre-intervention, 4 weeks after the start of the intervention, 8 weeks after the start of the intervention. Method of measurement: Variables are measured by demographic questionnaire and DAAS-21 scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety and depression in postmenopausal women. Timepoint: Pre-intervention, 4 weeks after the start of the intervention, 8 weeks after the start of the intervention. Method of measurement: Variables are measured by demographic questionnaire and DAAS-21 scale.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-10</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی اهواز</contact_name>
        <contact_address>Esfand Ave., Golestan Blvd., Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
